Methods and apparatuses for the disinfection of devices and other areas

ABSTRACT

A method and apparatus for the sanitization, detoxification, disinfection, high level disinfection, or sterilization of both the interior and exterior surfaces of an object, including those with lumens and/or channels of various sizes, within a closed space, or closed system of space, in addition to their surrounding atmosphere, and relates particularly, though not exclusively, to the generation of an aerosol including an anti-pathogen/toxin/fungal/sporicidal agent(s) or substance(s) (applied agent), or chemical neutralizing agent(s) or substance(s), by way of one or more ultrasonic nebulizer(s). However the applied agent used in the present invention may also be in the form of any gas, vapor, plasma, aerosol, or other form. The apparatus and method also includes an option to incorporate and utilize a means to wash the object. The present invention includes the application of a positive or negative air/gas pressure to the internal space, lumens, ducts, or channels, of an object.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a Continuation-In-Part of Continuation-In-Part application Ser.No. 13/052,199 (now U.S. Pat. No. 8,062,590), filed on Mar. 21, 2011 ofU.S. Nonprovisional application Ser. No. 12/567,428 (now U.S. Pat. No.8,110,156), filed on Sep. 25, 2009, which claims priority from U.S.Provisional Application Ser. No. 61/100,029, filed on Sep. 25, 2008, andall of the above patent documents are expressly incorporated byreference herein in their entirety.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to improved disinfection apparatuses andmethods for use of those apparatuses, including but not limited to thesimultaneous or non-simultaneous, sanitization, detoxification,disinfection, high-level disinfection, or sterilization of one or moreinternal and exterior surfaces, or areas, of objects or spaces, as wellas the airborne delivery of other types of agents, for various purposes,to one or more areas, and without limitation, the surfaces in thosearea(s). These areas may also include one or more surfaces that areinterfaced or articulated.

BACKGROUND OF THE INVENTION

The complete and assured sanitization, detoxification, disinfection,high-level disinfection, or sterilization of devices, tools and otherobjects in industries such as but not limited to the health careindustry, has always been a challenge in terms of processing time, cost,engineering tradeoffs, toxicity, safety, and overall effectiveness.Currently, the available choices are liquid disinfection, typicallyreferred to as a “wet” method, and various airborne methods, typicallyreferred to as a “dry” method. The dry method can include, but is notlimited to, gases, aerosols, and processes that use steam as a carriergas for the disinfecting composition or solution. All processes that donot include liquid immersion are generally considered to constitute adry method even if the agent used has a liquid phase.

Immersion of an object in liquids known in the art for sterilization ordisinfection is a relatively simple method that is cost effective, andoffers fast cycle times that are typically measured in hours. However,it also presents problems related to reproducibility and qualityassurance due to the potential for bubbles to form on the inner surfacesof complex instruments, including endoscopes, which prevent cleaningsolution contact with interior surfaces, such as lumens or channels.Another method for cleaning devices such as endoscopes is known to thoseskilled in the art, but generally involves several sequential steps oractivities such as, but not limited to, wiping the scope off to removeany unwanted debris or contaminants and then placing the endoscope in awasher and interfacing it with a hose, or other means known to thoseskilled in the art (herein called “supply tube”). The supply tubeenables various liquids including but not limited to, surfactant, highpurity rinse water, and disinfectant/sterilant, to be moved through thevarious channels and lumens of the endoscope at various stages of thecleaning process. The outside of the endoscope is also exposed,preferably simultaneously, to these same liquids at various stages ofthe cleaning process. After the final rinse stage, the endoscope isdried in a manner known to those skilled in the art including, but notlimited to, being dried within the processing chamber, or removed fromthe washer and dried outside of the processing chamber.

The current art can be improved in various ways including, but notlimited to:

(1) decreasing the time required to achieve the desiredanti-pathogen/toxin/fungal/sporicidal effect on both the internal andexternal surfaces as well as any interfacing/articulating surfaces of anobject or endoscope (2) reducing the risk that “air bubbles” willprevent full contact of the disinfectant/sterilant solution with allinner surfaces of an object or endoscope (3) reducing the drying timefor an object or endoscope, and (4) reducing or eliminating thedeleterious effect of the disinfectant solution and/or disinfectingprocess on the materials that are used to construct the object orendoscope. The methods and apparatuses of the present invention addressthese needs by decreasing the time to efficaciously complete theessential steps while achieving a satisfactory result.

In general, liquid disinfection/sterilization creates a majorcorresponding drawback in that the finished product remains wet, andtherefore unsuitable for packaging and/or storage. The deployed orapplied disinfecting agent(s) or substance(s) must have limitedtoxicity, be reasonably safe as well as compatible with those materialscomprising the instruments and devices to be disinfected/sterilized.

Gaseous agents used in the prior art for sterilization are very limitedin terms of medical applicability. Steam or dry heat sterilization iseffective, but many medical devices and instruments are incompatiblewith the degree of heat required for this process. So-called “coldsterilization” is an alternative, but the only currently available coldsterilization agents in use in hospitals are ethylene oxide and hydrogenperoxide in various forms that include, but are not limited to plasma.U.S. Pat. No. 4,512,951 (Koubek, 1983), which is incorporated herein byreference in its entirety, including any references cited therein,teaches using hydrogen peroxide to sterilize medical articles by causinghydrogen peroxide-water vapors to deposit a film of liquid on themedical devices. The liquid film is then caused to be evaporated.Hydrogen peroxide vapor is susceptible to humidity that can reduce theefficacy of the process.

Ethylene oxide (EtO) is carcinogenic, toxic and dangerous and, althougheffective, is only used as a last resort for instruments and devicesthat cannot be subjected to other modalities. In addition, after beingexposed to EtO, items cannot be used for long periods to allow“off-gassing” or aeration of the EtO. According to the UNC School ofDentistry, the complete EtO cycle, including aeration, can last as longas 24 hours. The newer technology utilizing hydrogen peroxide plasma isan alternative, however, it is very expensive, and the technologyrequirements have translated to only small size sterilization chambers.To date, it has not been capable of sterilizing certain instrumentsincluding, but not limited to, endoscopes. Endoscopes generally containsmall lumens and/or channels and the hydrogen peroxide plasma hasdifficulty in maintaining its effectiveness throughout the length of thelumen.

Without being limited to a mechanism, method, or chemical, it isbelieved that chemically reactive liquids are necessary in sterilizationprocesses to contact contaminants including but not limited to toxins,bacteria, virus, fungus, and spores (both fungal and bacterial), prionsor protein structures, within a target area(s) to either kill orneutralize the bacteria, virus, fungus, and spores, or to render thetoxin, virus, or protein structure incapable of replication or tootherwise interfere with the target's cellular physiology, or to destroyor neutralize the toxin. These chemically reactive liquids may beprovided as an aerosol.

Prior art has taught that relatively quick disinfection andsterilization of objects can be achieved by their exposure to an aerosolof a disinfectant/sterilizing agent created by ultrasonic nebulization.U.S. Pat. No. 4,366,125 (Kodera et al., 1980), which is incorporatedherein by reference in its entirety, including any references citedtherein, teaches that an aerosol, created by ultrasonic transducers andconsisting of hydrogen peroxide, can contact surfaces targeted forsterilization. Ultraviolet-ray lamps are then synergistically used inconcert with the applied aerosol to achieve sterilization of thetargeted surfaces. Generally, the prior art also describes apparatusesand methods where the aerosol is generated by one or more ultrasonictransducers located below the surface of a reservoir containing aliquid. The output of the transducers is focused to either a pointand/or directed toward an area near the surface of the liquid to cause asurface disturbance, which results in the formation of an aerosol fromthe liquid. The transducers used in these apparatuses are typically madefrom lead-zirconate-titanate-four (PZT-4) or other piezoelectricmaterials. This material is coated with a conductive coating (i.e., anelectrode material) that enables an electrical signal to energize thetransducer and causes it to emit high frequency pressure (energy).

G.B. Patent No. 1,128,245, (Rosdahl et al., 1968) which is incorporatedherein by reference in its entirety, including any references citedtherein, describes a device for disinfecting apparatuses andinstruments, including medical instruments. This apparatus alsogenerates a mist of disinfectant, including hydrogen peroxide, by meansof an ultrasonic aerosol generator. According to Rosdahl et al., thispatent was “primarily adapted for the disinfection of small medicalinstruments such as scalpels, tongs, syringes, or the like, positionedon a grid in a container” (pg 3 col. 23-30). However, another separateintended use for a second described apparatus was for disinfectinginterior surfaces of objects such as the interior of tubing used for“breathing apparatuses” and “heart lung machines” (pg 1 ln 30-36 and pg2 ln 95-101).

Rosdahl et al. is distinguished from the present invention in that it issilent with respect to simultaneously disinfecting both the interior andexterior surfaces of an object. Rosdahl et al. also does not teach amethod for simultaneously sterilizing/disinfecting and drying theoutside and interior surfaces/lumen of an object. Most importantly,Rosdahl et al. does not teach how the apparatus could effectively andefficaciously be “connected” to the object (pg 2 ln 95-101) in a waythat enables all of the interfaced/articulated surfaces to be sanitized,disinfected, high level disinfected, or sterilized. The pressurized airin Rosdahl et al. is supplied by way of a fan etc. or carrier gas, (pg 2ln 48-49) and is used to both move the generated aerosol to perform thedisinfection function, and to dry the objects placed within the enclosedarea of their described apparatus after disinfection. Rosdahl et al.incorporated “a heating element in the flow path of the carrier gas, toincrease drying efficiency” (pg 3 ln. 123-127) by heating the air. Theuse of a heating element in the flow path of a gas stream taught in U.S.Pat. No. 6,379,616 (Sheiman, 1999), is incorporated herein by referencein its entirety, including any references cited therein. Sheiman alsoteaches the use of ultrasonic transducers to generate aerosol. Theheater is located about the inlet conduit of the apparatus and isdesigned to heat the aerosol, which encourages its condensation on orwithin the article. It is important to note that Sheiman is silentregarding the use of the apparatus or a secondary apparatus to interfaceand sanitize, disinfect, high-level disinfect, or sterilize, theinterior of an object or device, as well as the simultaneous ornon-simultaneous cleaning of both the interior and exterior of objects.

Ultrasonic nebulizers have a unique advantage in that they can createsmall aerosol droplets less than 5 microns in size. The size of thedroplets enables them to penetrate small cracks and crevices and tobehave like a gas due to Brownian movement and diffusion. In addition,the cloud is able to form a very thin coating, deposition, or film overvarious surfaces that is inherent to this technology and method. Thethin coating, film, or deposition of sterilant or disinfectant is ableto dry much faster than coatings created by aerosol containing dropletsthat are much larger in diameter. It is also theorized that the vaporcomponent contributed by the evaporation of the generated droplets, oreven partial touching of the aerosol droplets with the targetedcontaminant(s) can contribute to the overall efficacy of the process.

U.S. Pat. No. 4,366,125, (Kodera et al., 1980), which is incorporatedherein by reference in its entirety, including any references citedtherein, teaches that heated H2O2 was more efficacious than H2O2 used atroom temperature (col. 1, line 19-25). In other words, (Kodera et al.,1980) teaches that the efficacious nature of a liquid agent can beincreased as it is heated to temperatures higher than ambienttemperature. This is desired, without limitation, in the presentinvention. The text entitled, “Aerosol Technology” by William C. Hinds(1982), which is incorporated herein by reference in its entirety,including any references cited therein, also taught that the size of theaerosol particles produced by ultrasounic means are not only affected bythe frequency of the transducer operation, but also by the surfacetension and density of the liquid.

It is commonly known that heating a liquid to a temperature less thanits boiling point will reduce its surface tension. William C. Hinds(1982) established that the higher the temperature of the liquid, thelower the liquid's surface tension, resulting in smaller sized aerosolparticles. This principal is incorporated without limitation, in thepresent invention. In the same text he also taught that smaller diameterparticles demonstrate characteristics such as but not limited to, alower settling velocity, a higher diffusion coefficient, and a higherBrownian displacement (movement), which is desired, without limitation,in the present invention. Hinds further taught that ultrasonic aerosolgenerating transducers can heat the surrounding liquid (page 382). Thisis also desired, without limitation, in the present invention.

Despite the advantages that ultrasonic nebulization offers, currently ithas major limitations in its usefulness and has not been successful inmeeting the needs of medical sterilization. For example, and withoutlimitation, it is difficult and time consuming with the prior artdevices and methods to disinfect or sterilize both the exterior andinterior surfaces of tools or equipment, e.g., endoscopes, in a singlecleaning cycle or process due to their complex construction includingnarrow lumens of various length. The limitations of the prior art arefurther indicated by the failure or problems which variousanti-pathogen/toxin/fungal/sporicidal agents or substances have incontacting, and/or rapidly achieving an efficacious result on, thesurfaces of the endoscope or object that are interfaced/articulated withany coupling(s) or other device.

“Flash” sterilization is also needed in industries such as, but notlimited to the health care industry. It is commonly used for quicksterilization and turn around of various objects immediately needed foror during surgery. Flash sterilization methods that include the use ofsteam under pressure at recommended temperatures of approximately 270degree Fahrenheit for approximately three to ten (3 to 10) minutes, aregenerally representative of the current art. The object that is flashsterilized must then cool down before it is used, which also takesvaluable time. A need still exists in the industry to further reduce thetotal amount of time it takes to clean, sterilize or disinfect, anddeliver a surgical tool on demand within a reasonable period of time.The present invention can, without limitation, decrease the total cycletime needed for rapid sterilization of medical devices by providing ameans to quickly sterilize or disinfect objects whose constructionmaterials are thermally sensitive and cannot be flash sterilized bycurrent means.

The methods and apparatuses of the present invention address the needfor a quick and effective way to fully sanitize, detoxify, disinfect,high level disinfect, or sterilize both the interior and exterior ofmedical devices, and objects. In addition, this may without limitation,be accomplished while still enabling all surfaces of the object orendoscope to have contact with the anti-pathogen/toxin/fungal/sporicidalagent(s) or substance(s) includeing surfaces of the object or endoscopethat are interfaced/articulated with any coupling(s) or other device.

SUMMARY OF THE INVENTION

The present invention generally relates to a combination of variousapparatuses and methods for the sanitization, detoxification,disinfection, high level disinfection, or sterilization of both theinterior and exterior surfaces of an object or medical device, includingany articulating surfaces of interest, or plurality of objects withinone or more closed space(s), closed system of space(s), or chamber(s),of any space, size, shape, configuration, or construction, that iseither sealed or unsealed (Hereinafter called “sterilization chamber”).In order to accomplish this, anti-pathogen/toxin/fungal/sporicidalagent(s) or substance(s) are first created, generated, and/oradministered in or into the sterilization chamber. It is preferredwithout limitation, that the objects, e.g., endoscopes, are washedaccording to the manufacturer's recommendations or methods common to theindustry, before being placed inside of the sterilization chamber.However, the washing and cleaning activities can also take place withinthe sterilization chamber prior to the application of theanti-pathogen/toxin/fungal/sporicidal agents(s) or substance(s).

According to an embodiment, any anti-pathogen/toxin/fungal/sporicidalagent(s) or substance(s) to be applied or used (hereinafter “appliedagent)”), may be in the form of a gas, vapor, plasma, or aerosol. It ispreferred in the present invention that the “applied agent” is anaerosol, including, but not limited to, any acidic oxidizer, generatedby one or more ultrasonic nebulizer(s). Transducers of any design,frequency, or construction may be used. The aerosol may be created byany means and may be of any concentration, number, size, or density,however it is preferred, without limitation, that the aerosol generallyincludes droplets whose size is five micron or less. It is preferredwithout limitation that the aerosol has a higher rather than lower massconcentration or density of droplets. In addition, any substance may beapplied to neutralize any chemical residue on the interior or exteriorof an object and/or device.

As previously discussed, the prior art is limited because of thedifficulty that an “applied agent” has in reaching the interior surfacesof objects or the lumen or channels found in an endoscope in a shortperiod of time. Quicker turn-around times may be accomplished byimproving the current art by means including, but not limited to:decreasing the processing time or exposure time to the “applied agent”,decreasing the drying time of the object.

The prior art is further limited because of the difficulty of the“applied agent” or substance to reach surfaces that areinterfaced/articulated with a coupling(s) or other devices orcomponents.

The present invention addresses the failure of the prior art to treatthe articulating surfaces of an endoscope and coupling by incorporatingan innovative porous and/or permeable interface between the endoscopeand coupling. This innovative porous and/or permeable interface assuresthat the “applied agent” is able to reach the entirety of the internalspaces and surfaces, including endoscope lumens, channels, internal andexternal spaces and surfaces. One of the critical factors for thissolution is the interface between the supply of the negative or positiveair/gas pressure that is used to bring the “applied agent”(s) orsubstance(s) in contact with all surfaces of the endoscope. The porousand/or permeable interface of the present invention not only providesthe necessary positive or negative air/gas pressure, but moreimportantly, it is able to do so while still insuring that all of thesurfaces including the interface have sufficient exposure to the“applied agent”. While this innovative system and method could beapplied to other airborne sterilization systems and “applied agent”s, itis preferred in the present invention that transducer based ultrasonicnebulization is utilized and exploited. It is also important to notethat this particular aspect of the present invention could easily beadapted for use with any “applied agent” that can be applied to anysurfaces of the tool or endoscope in liquid form such as, but notlimited to a jet or stream of disinfecting or sterilizing liquid ormixture of liquids as taught by U.S. Pat. No. 5,425,815, (Parker et al.,1995) incorporated herein by reference, and not via any airborne,aerosol or gaseous modality.

These advantages include, but are not limited to: 1) the ability tooffer large chambers in which the tools to be disinfected can bepositioned and treated without the technical challenges and costsassociated with EtO and plasma; 2) the ability to build simple glass orplastic see-through chambers; 3) the ability to incorporate the additionof one or more polymer glove(s) or finger(s), built into the wall(s) ofthe closed space or sterilization chamber (similar in purpose and designto what is found in common laboratory or industrial glove boxes); 4) thevery rapid processing times associated with the ultrasonically-generatedaerosols introduced into the chamber; and 5) the ability to utilize awide range of liquid disinfection or sterilization agents or mixtures ofagents compared to the extremely limited number of gaseous, vapor andplasma options.

The aerosol created by the ultrasonic nebulizer(s) is generated by oneor more ultrasonic transducers located below the surface of a liquidagent. The transducer(s) energy output is focused to either a pointand/or an area near the surface of the liquid causing a surfacedisturbance, which results in the formation of an aerosol of the agent.Each transducer used in this apparatus is made fromlead-zirconate-titanate-four (PZT-4), or other piezoelectric materials.The transducer(s) are operated in the frequency range of 0.001 to 10.0MHz. The resultant aerosol is then evacuated from the reservoir and/orchamber in which it is made, by a blower or other source of pressurizedair, and moved into the designated or targeted space or closed area orchamber (Hereinafter “sterilization chamber”). After its utilization indisinfecting or sterilizing a tool, the aerosol can then be circulatedback to the aerosol generation chamber. This is taught in U.S. patentsKodera et al. U.S. Pat. No. 4,366,125 and Sheiman, U.S. Pat. No.6,379,616. Recirculation can also be applied to any gas, plasma, vapor,aerosol, or other form of an “applied agent” or substance. Theaersolized agent within the sterilization chamber may be moved withinthe chamber by a blower, fan, or other source of pressurized air.

U.S. Pat. No. 4,366,125, (Kodera et al., 1980), which is incorporatedherein by reference in its entirety, including any references citedtherein, describes an improved method and device involving ultrasonicnebulization that includes a means to heat the liquid which isnebulized. Kodera et al. teaches that heated H2O2 was more efficaciousthan H2O2 used at room temperature (col. 1, line 19-25). In other words,the efficacious nature of a liquid agent can be increased as it isheated to temperatures higher than ambient temperature. It is preferred,without limitation, that this advancement in the art is incorporatedinto the present invention.

Sheiman, U.S. Pat. No. 6,379,616 also improves upon the art byincorporating a heating element operatively coupled to the inlet of theclosed area or sterilization chamber. According to Sheiman, the purposeof the heating element is to provide a means for effecting condensationof the aerosol within or on the article. This could also be incorporatedinto the present invention as described.

An embodiment of the present invention includes, without limitation, apossible means for radiating heat that is either operatively coupled toand/or about the outlet(s) of the closed area or sterilization chamber,or anywhere past the said outlet(s) and along the path of the air andaerosol as it is recirculated from the closed space or sterilizationchamber back into the aerosol generation chamber(s). The purpose of thisembodiment is to further diminish the diameter of the aerosol dropletsbefore they reach the interior of the aerosol generation chamber(s) byheating the aerosol, and thereby reducing the possibility of theircoalescence into larger droplets.

Another embodiment of the present invention includes, withoutlimitation, the possible addition of a means to heat the floor withinthe closed space or sterilization chamber. A heated plate(s) could alsobe placed in this location. The purpose of having a heated surface atthe bottom of the closed space or sterilization chamber is to repel thedownward trajectory of the aerosol droplets as a result of gravity orthermal forces. In addition, droplets that contact the heated surface(s)may be re-energized or transformed into a vapor. This will contribute tothe efficacious nature of the overall process and further decreaseaggregate settling velocity. It is important to note that care should betaken in placement of this heated surface, so that an item(s) placed inthe chamber is not heated. Increased heat causes the droplets to berepelled thus reducing the efficacy of the process.

An apparatus and method of another embodiment of the present inventioncomprises placing one or more endoscope(s), tool(s) or object(s), in aclosed space or sterilization chamber with the addition of a means toenable the sanitization, detoxification, disinfection, high leveldisinfection, or sterilization of the interior area or surfaces,lumen(s), and/or channel(s) of the endoscope(s) or object(s). This meansis able to interface or connect positive air/gas pressure or negativeair/gas pressure (vacuum) line(s) with an object or endoscope inside ofthe sterilization chamber, and move “applied agent”(s) or substance(s)through the entire object or endoscope with sufficient volume andvelocity without compromising the ability to treat contamination of thearea or surfaces under or between that interface or connection and themedical device. It is preferred, without limitation, that theaforementioned object be washed, cleaned, or rinsed, before it is placedwithin the sterilization chamber.

This particular embodiment utilizes an innovative pressure interfaceassembly including a coupling and interface or interface materialcombination that is unique for this application. This assembly isinterfaced/articulated with an open end of the object or the distal endof the endoscope where the lumen/ports/working channels exit.

The pressure interface assembly has a number of components that include,without limitation, a porous and/or permeable interface or interfacematerial (hereinafter called “interface”) and a coupling. The couplingmay be constructed from various materials such as but not limited tostainless steel, glass, cellulose, polyolefin, paper, polymer, naturalor manufactured fibers or materials, that may be coated or uncoated, orconstructed with combinations of these materials, or other materialsknown in the art. The coupling may be rigid, semi-rigid, or flexible.The coupling may have one or more ports or other means for attachingtubes, hose, pipes, duct, tunnels, conduit etc. (hereinafter called“delivery pipe”) that can supply air, gas, or the “applied agent” to thevarious spaces and surfaces of the pressure interface assembly andendoscope, including without limitation their internal spaces andsurfaces, under positive or negative pressure.

The interface assembly can be used, without limitation, to dry theendoscope or to push or pull the “applied agent”(s) or substance(s)through any of its internal spaces, lumen or channels. The coupling canbe designed so that one end is able to fit over an end of the endoscopeand the other end of the coupling is designed to interface or connectwith the delivery pipe. The coupling may also have various opening sizeson one end and various opening sizes on the other. The end of thecoupling that is designed to fit over an end of an endoscope can alsohave one or more openings of various shapes and geometries. This openingcan control the negative or positive air/gas flow or pressure in or outof the coupling. The internal dimensions of the coupling are designed toallow it to fit over the end of the endoscope and interface/articulatewith the interface that is positioned between the coupling and theendoscope. The thickness of the coupling as well as the material(s) fromwhich it is constructed, may also contribute to the efficaciousperformance of the interrelationship between the coupling, interface andendoscope, and their surfaces.

The interface is designed so that its internal dimensions provide asufficiently tight fit with the outside dimensions of the endoscope orobject. Attributes such as but not limited to the width, thickness,porosity and/or permeability, flow of “applied agent” or gas,absorbency, as well as other chemical, mechanical, and physical(including durometer) properties of the interface may also contribute toan effective interface. The interface is either slipped over the end ofthe endoscope or at least a portion is mounted inside of the coupling,or combinations thereof. The coupling is then fitted over the end of theendoscope so that the endoscope interfaces sufficiently with theinterface material and the interface material interfaces sufficientlywith the coupling. The coupling is designed so that its internaldimensions provide a sufficient fit with both the contacted interfacematerial and the endoscope. In certain situations, the thickness of thecoupling material may also contribute to a sufficiently sealed orinterfaced system.

Attributes such as but not limited to the interface material utilized,porosity and/or permeability of the interface, absorbency of theinterface, as well as other chemical, mechanical, and physical(including durometer) properties, the interface thickness and width, thefit of the interface to the endoscope or object, the pressure exerted bythe fit of the coupling to the interface and endoscope or object, andthe distance the coupling overlaps on the interface material, controlsthe rate of air/gas flow through the interface which then directlyimpacts the air/gas pressure differential between the inside and outsideof the coupling.

It is important that the air/gas pressure differential be controlled sothat a sufficient air/gas pressure differential exists to achieve ananti-pathogen/toxin/fungal/sporicidal effect on both the area andsurfaces under the interface and the internal surfaces inside of theendoscope. These variables can be optimized for each object or endoscopeconfiguration and coupling configuration based on, but not limited to,its external and interior dimensions, choice of permeable and/or porousmaterial, internal area, and number, size and length of their interiorareas.

There are two main components or features of an effective interface inthis assembly. First, the interface must be porous or permeable. Thisallows the “applied agent” to pass through it. The air/gas, as well asthe “applied agent” (if applicable) may also, without limitation, passthrough the interface at a controlled and/or limited, but effectualrate. The passage of the “applied agent” through the interface materialallows the area and surfaces under the interface material to be exposedto, and acted upon, by the “applied agent” in order to achieve thedesired level of sanitization, detoxification, disinfection, high leveldisinfection, or sterilization. The interface may have absorbentcharacteristics to improve its efficacy. The composition of theinterface material is not limited to but could be as simple as cottongauze or some other substrate made of natural or manufactured fibers.The interface may also be constructed from one or more layers of variousmaterials or combinations of materials such as but not limited to,cloth, gauze, manufactured fibers, synthetic fibers, natural fibers ormaterials, cellulose, polyolefin, polymer, or other materials known inthe art, in order to control attributes such as, but not limited to,absorbency, and the flow rate or passage of the “applied agent” throughthe interface material as desired.

The limitation and/or control of the rate of flow of air/gas and/or“applied agent” allows the present invention to create an effectivenegative or positive air/gas pressure to move the “applied agent”through the interior space, lumens, and/or channels of the endoscope, aswell as through the interface. For instance, if a vacuum is applied tothe coupling interfaced/articulated with the interface material, the“applied agent” will be pulled through both the interface materialand/or the areas of articulation as well through the interior spaceand/or lumens or channels with sufficient velocity to assureanti-pathogen/toxin/fungal/sporicidal activity on the surfacesthroughout the length of the interior area, lumen, or working channelsof the object or endoscope and in the area and on the surfaces under theinterface.

The second feature of an effective interface involves the applicationand/or control of an effective pressure exerted on the interface as itcontacts the object or endoscope. This assures a sufficient flow of“applied agent” through all areas of the interface and results inobtaining the desired level of sanitization, detoxification,disinfection, high level disinfection, or sterilization of the entirearea and surfaces under the interface. It is preferred withoutlimitation that the pressure exerted on the interface is evenlydistributed.

According to another embodiment, the applied pressure is effectual andefficacious. The exerted pressure on the interface can also result fromthe interface/articulation of the coupling and interface material withthe endoscope. The effectiveness of the interface/articulation may alsobe augmented or optimized by the application, bonding, or interpositionof one or more layers of various materials or combinations of materialssuch as but not limited to, cloth, gauze, manufactured fibers, syntheticfibers, natural fibers or materials, cellulose, polyolefin, polymer, orother materials known in the art. The exerted pressure on the interfacematerial can result, or be further controlled or optimized, from theinterface/articulation of the coupling and interface material with theobject or endoscope. It can be further controlled or optimized, by theuse of an inflatable pillow, balloon, bladder, reservoir, or otherinflatable or expandable means or material (hereinafter called“balloon”) between the coupling and interface material, between theendoscope and the interface material, between the endoscope and thecoupling, on the internal surface of the interface, and/or around thecoupling. The balloon can also be constructed of and/or have itsoutermost layer constructed of this interface material and function asthe interface layer. In either case involving the balloon, varying theamount of pressure inside of the balloon controls the pressure exertedon the interface. Additional means can be used to exert pressure on thecoupling, interface material, and endoscope in order to create at leasta minimum working interface, and are known to those who are skilled inthe art. One example is a clamp that fits over and is used to applypressure to the coupling, interface material and endoscope to create asufficient working interface. In another example, a ring of material canbe incorporated into the coupling and the ring is able to exerteffective and, preferably evenly distributed pressure on the interfacematerial.

It is also possible to exclude the interface component of the pressureinterface assembly, and for the coupling to function as an interface tothe endoscope, which represents this embodiment and the pressureinterface assembly in its simplest form. In this alternative, the entirecoupling, part of the coupling, or the end of the coupling thatinterfaces with the object or endoscope, is constructed from, or islaminated, glued, cemented, adhered, or otherwise attached, to theinterface previously discussed. Effective, and preferably evenlydistributed, pressure can be exerted on the interface material by wayspreviously discussed, and can include, but not limited to the exertionof pressure from the inflation of an inflatable pillow, balloon,bladder, reservoir, or other inflatable or expandable means or material(balloon) either between the interface layer and the coupling, inside ofthe coupling walls, or on the exterior surfaces of the coupling.Everything previously discussed pertaining to the coupling and sealmaterial applies to this embodiment. In general, the coupling isdesigned, constructed, treated, or processed, so that a pressuredifferential is able to be established that results in the effectiveflow of an applied agent or substance through both the interior space ofthe endoscope and the interface that is in contact with the endoscope,resulting in an anti-pathogen/toxin/fungal/sporicidal effect on areasand surfaces that include, but are not limited to, the areas andsurfaces surrounding and under the seal material.

Another embodiment of the present invention includes the supply ofair/gas, that is under either negative or positive pressure, to thepressure interface assembly by using a means such as, but not limitedto, a vacuum pump, air/gas pump, pressurized air source, fan, or blower.This air pressure serves several functions. First, the positive and/ornegative air/gas pressure can be applied to the pressure interfaceassembly at the beginning and/or end of the treatment, sanitization,detoxification, disinfection, high level disinfection, or sterilizationcycle, or at any time during the entire cycle, in order to move air/gasor dry and/or heated air/gas through the interior space, lumens, and/orchannels of the endoscope. This can remove any moisture if it is presentin these areas. One or more heating element(s) placed in the air streambefore the pressure interface assembly can also, without limitation,provide heated air (Rosdahl et al. pg 3 Col. 123-127). It is preferred,without limitation, that any air from outside of the sterilizationchamber that is pulled, drawn, pushed, or otherwise moved into thesterilization chamber and/or the endoscope is first filtered before itsentry into the sterilization chamber and endoscope with, withoutlimitation, any high efficiency filter such as a HEPA filter(s) or otherfilter(s) that is known to those skilled in the art and/or is acceptablein the industry in which it is used. The air/gas may also be filteredwith any type of filter before its exit from the sterilization chamber,and the filter(s) is known to those in the art and/or is acceptable inthe industry in which it is used. The air can also be heated within thesterilization chamber and/or before its entry into the sterilizationchamber from outside, in order to help dry the object/endoscope.

The positive air/gas pressure or negative air/gas pressure is alsointended, without limitation, to move the “applied agent” or substancethrough the interior space of the endoscope as well as through theinterface and the area under the interface. It is preferred, withoutlimitation, that if a negative air/gas pressure is supplied to thecoupling that a pressure differential is established. This results,without limitation, in the flow of air/gas and “applied agent” orsubstance from the sterilization chamber, through the interfacematerial, the area under the interface, and the internal space withinthe endoscope, and into the coupling. Once in the coupling, the air/gasand/or “applied agent” flows into the attached tubes, hose, pipes, duct,tunnels, conduit, or delivery pipe, where it is eventually vented backinto the sterilization chamber, or through a filter and into the outsideenvironment.

The “applied agent” can also, without limitation, flow into the couplingunder positive air/gas pressure. It is preferred, without limitation,that in this case, the “applied agent” or substance is pulled from thesterilization chamber, or a chamber where it is generated, and flowedinto the coupling via the attached tubes, hose, pipes, duct, tunnels,conduit, or delivery pipe. It is then, without limitation, flowed out ofthe interface material, the area under the interface material, andthrough the internal space within the object or endoscope, and into thesterilization chamber. The “applied agent” or substance in this case,can without limitation, be separately delivered into the sterilizationchamber, if it is generated in a chamber separated from thesterilization chamber.

Another embodiment of the current invention is the incorporation,positioning, or placement, of one or more biological indicator(s) and/orchemical exposure indicator(s) in or articulated with the pressureinterface assembly. It is preferred in the present invention that theindicator(s) is placed or positioned inside the coupling. Theindicator(s) provides a method of assuring that proper sanitization,detoxification, disinfection, high level disinfection, or sterilizationhas occurred within the pressure interface assembly.

An apparatus and method of another embodiment of the invention comprisesthe incorporation of a means to flow or circulate either filtered orunfiltered air/gas from outside of the apparatus into the sterilizationchamber. This air/gas can also be flowed through the interior space,lumens, and/or channels of the endoscope inside of the sterilizationchamber by using the same means that is used to supply positive ornegative air/gas pressure to the pressure interface assembly that isinterfaced with the endoscope. This air may be heated, and it helps toremove moisture from any of the surfaces of the endoscope(s) within thesterilization chamber as well as the surfaces of their interior areas,lumen or channel(s). This activity can transpire at any time including,but not limited to, before the application of the “applied agent” orsubstance. In addition, and without limitation, the completion of thisactivity at the end of the sanitization, detoxification, disinfection,high level disinfection, or sterilization cycle can decrease the entirecycle/processing time. When an “applied agent” or substance is applied,such as but not limited to an aerosol, this activity can also reduce therelative humidity in the sterilization chamber to ambient or belowambient levels. The incoming air can be, without limitation, effectivelyfiltered with the use of any high efficiency filtering process, or otherfiltering means known in the art. The sterilization chamber can also,without limitation, be coupled to a filtered exhaust system to allow theincoming filtered air to replace air inside the chamber.

An apparatus and method of another embodiment of the present inventioncomprises the incorporation and use of any apparatus or methods know tothose skilled in the art, to remove humidity from within thesterilization chamber(s) or other targeted area(s). This should not beconfused with a fan or blower that was previously mentioned. Thedehumidification apparatus may, without limitation, be placed orinterface with or within the sterilization chamber(s) or other connectedareas or spaces. The dehumidification apparatus may be operated any timeafter the application of the “applied agent”. After the endoscopeprocessing steps are completed and the sterilization chamber(s) or othertargeted area(s) are dehumidified, the air/gas within these spaces maybe, without limitation, filtered to remove substances such as, but notlimited to, any remaining odors, chemicals, smells, vapors, aerosols, orgases. Any filtering means or level of filtering may be utilized and isknown to those skilled in the art. The processed air/gas may be, withoutlimitation, returned back to the sterilization chamber(s) or anyspace(s) connected to the sterilization chamber(s), and this allows,without limitation, the system or process to be self contained until thesterilization chamber is opened at the end of the operation cycle.

An apparatus and method of another embodiment of the present inventioncomprises the incorporation of a means for holding or positioning theendoscope so that all of its surfaces are exposed to the “applied agent”and are also able to dry during the drying cycle(s). An apparatus andmethod of another embodiment of the present invention comprises theinclusion of a means for holding or positioning the endoscope, which isexposed to the applied agent, in the sterilization chamber. To date, onehurdle for many sanitization, detoxification, disinfection, high leveldisinfection, or sterilization systems is the problem with shadowing, orinadequate coverage, when one hard or impenetrable surface touchesanother.

According to one embodiment of the present invention, the endoscope isheld about its circumference with a loop, band or it is cradled, in oneor more places with a porous, permeable, semi-permeable and/or absorbentmaterial and the remaining material is then placed on hooks or otherholding mechanisms positioned within the sterilization chamber so thatthe object or endoscope can hang in free space within the sterilizationchamber. Without limitation, previous tests have shown that certainporous materials like glassine have shown sufficient permeability withthis process to obtain a high level of disinfection on the internal sideof the barrier material.

According to another embodiment of the present invention, the endoscopeis placed on one or more beams or forks (hereinafter“Start Beams”) thatare located within the sterilization chamber. These beams or forks canbe of various sizes and shapes and interplay or loosely interlock withopposing beams or forks (hereinafter“Opposing Beams”) that can be ofsimilar shape and size. During the application of the “applied agent”either t “Start Beams” or “Opposing Beams”move by way of variousmechanical means know in the art, and take hold of the endoscope so thatit is transferred from the Start Beams to the Opposing Beams or from theOpposing Beams to the Start Beams. This process can be reversed duringthe drying cycle(s). This process can be timed so that all surfacesreceive a sufficient or efficacious exposure to both the “applied agent”and drying cycle.

According to an embodiment, it is more preferred, without limitation,that one or more endoscopes is placed within an enclosed area, chamber,or sterilization chamber, and the internal and external surfaces of theendoscope are simultaneously or non-simultaneously subjected to variouscombinations of activities including, but not limited to, washing,cleaning, rinsing, drying, disinfection/sterilization, in variousorders, frequency, and duration. Some of these activities may not beundertaken. This embodiment improves the current methodology for thedisinfection or sterilization of an endoscope.

The initial processing or cleaning of an endoscope in this embodimentincorporates activities already known to those skilled in the art. Theseactivities may include, but are not limited to, (1) Wiping, or otherwisecleaning the endoscope in various ways known to those skilled in theart, to remove any liquids, debris, contaminants, blood, mucus, feces,urine, or other substances that are unwanted or undesirable; (2) Placingthe endoscope into a chamber, washer, or other device or means forcleaning, washing, or otherwise disinfecting/sterilizing endoscopes orother objects (hereinafter called “washer”); (3) Securing or holding theendoscope within the washer, (4) Interfacing the endoscope with a hose,tube, or other delivery means known to those skilled in the art(hereinafter “supply tube”) in which the supply tube enables variousliquids including, but not limited to, surfactants, and high purityrinse water, to be moved through the various channels and lumen of theendoscope at various stages of the cleaning process; (5) Operating thewasher to subject, spray, cover, flood, or any combination thereof,various surfaces such as but not limited to, the inside and/or outsidesurfaces of the endoscope, with liquids or compounds such as, but notlimited to, surfactants or other cleaning liquids; (6) Operating thewasher to subject, spray, cover, flood, or any combination thereof,various surfaces such as but not limited to, the inside and outsidesurfaces of the endoscope, with liquids or compounds such as, but notlimited to, any liquid rinse (Hereafter“rinse” or “rinse water”), whichmay be formed of any liquids or combination of liquids such as, but isnot limited to, high purity water. In order to improve the art anddecrease the endoscope processing time, improvements are made after thisparticular “rinse” activity to the current art and are shown in thefollowing embodiments. The endoscope processing or cleaning is completedin the current art by the following activities: (7) Applying adisinfectant to both the interior and exterior surfaces of the endoscopein various ways known to skilled in the art such as, but not limited to,being pumped or sprayed onto the various internal and external endoscopesurfaces; (8) Rinsing the interior and exterior surfaces of theendoscope in various ways known to skilled in the art such as, but notlimited to, pumping or spraying high purity water onto the variousinternal and external endoscope surfaces; (9) In many applications theendoscope surfaces may also, without limitation, be rinsed in a mannerknown to those skilled in the art, with a volatile solution such as, butnot limited to, alcohol, and this can also replace the high purity rinsewater mentioned above; (10) Drying the internal and external surfaces ina manner known to those skilled in the art; (11) Removal of theendoscope from the washer or chamber.

According to an embodiment, after the endoscope is treated withsurfactant and, without limitation, rinse water, its internal andexternal surfaces may, without limitation, be dried before applicationof the “applied agent”. The internal surfaces may, without limitation,be dried with air/gas flow through one or more supply tubes in a mannerknown to those skilled in the art, and the external surfaces may bedried with various means known to those skilled in the art. Theapplication of the “applied agent” may, without limitation, be followedby another rinse water cycle, volatile liquid rinse cycle, and/or dryingcycle. However, to further reduce processing time, it is preferredwithout limitation, that the internal and external surfaces of theendoscope are dried in a final drying activity in a manner known tothose skilled in the art, after the application of the “appliedagent”(s). It is possible, without limitation, to skip the final rinsingactivity(s) for reasons including, but not limited to, aerosols such as,but not limited to, ultrasonically derived aerosols, are able to beadministered to the endoscope's surfaces as a thin film of a lowconcentration of peroxyacetic acid, which then breaks down into harmlesscomponents as it dries and is not detectable once it is fully dry. Thisparticular embodiment may, without limitation, improve the current artby significantly decreasing the overall endoscope or object processingtime, as well as increasing the efficacy of the process.

According to an embodiment, after the endoscope is cleaned withsurfactant and/or rinsed, the inside and outside surfaces of theendoscope are treated with one or more “applied agent”s that is in theform of any aerosol. It is preferred, without limitation, that theinternal and external surfaces of the endoscope may, without limitation,be dried in a manner known to those skilled in the art, before the agentis applied. The “applied agent”s are created, generated, and/oradministered in or into the sterilization chamber in which the objectsare placed. It is preferred, without limitation, that the aerosol is anyaqueous aerosol that is generated or created by any transducer orultrasonic nebulizer of any construction and design. The “appliedagent”s may be pushed or pulled through the endoscope with various meansknown to those skilled in the art. The agents may, without limitation,be first administered or deployed into the sterilization chamber andthen pulled through the endoscope with a vacuum or negative air/gaspressure. This particular embodiment may, without limitation, improvethe current art by significantly decreasing the processing time.

According to an embodiment, the agents may also be, without limitation,in the form of any gas, vapor, plasma, or aerosol. The prior artincludes the use of pumping, jetting/spraying, or flowing agents as aliquid over the external surfaces as well as through the lumens andchannels of an endoscope for disinfection/sterilization purposes, and istherefore not claimed in the present invention.

According to another embodiment, after the various endoscope surfacesare treated with an agent, the internal surfaces, as well as externalsurfaces of the object or endoscope may be, without limitation, exposedto another rinse liquid, which may be formed of one or more liquids thatincludes, but is not limited to a high purity water, all in a mannerknown to those skilled in the art. After the “applied agent” or finalrinse liquid is applied, all of the endoscope surfaces may also, withoutlimitation, be rinsed with a volatile solution such as, but not limitedto an alcohol solution. The endoscope can then be removed from thewasher and hung to dry.

According to another embodiment, and without limitation, the internaland external surfaces of the endoscope may be dried with means includingbut not limited to, dehumidification of the air within the chamber,and/or air/gas or heated air/gas before the endoscope is removed fromthe washer. The supply tube may, without limitation, provide the air/gasthat is used to dry the internal surfaces, and the various externalsurfaces are dried in a manner known to those skilled in the art.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawing figures illustrate the best mode currently contemplated ofpracticing the present invention.

In the drawings:

FIG. 1 is a schematic view of a first embodiment of a disinfectingapparatus constructed according to the present invention;

FIG. 2 is a schematic view of a second embodiment of the disinfectionapparatus of FIG. 1;

FIG. 3 is a schematic view of an aerosol generator used in the apparatusof FIG. 1;

FIG. 4 is a schematic view of a first embodiment of a sterilizationchamber used in the apparatus of FIG. 1;

FIG. 5 is a schematic view of a second embodiment of a sterilizationchamber used in the apparatus of FIG. 1;

FIG. 6 is a schematic view of a third embodiment of a sterilizationchamber used in the apparatus of FIG. 1;

FIG. 7 is a schematic view of a fourth embodiment of a sterilizationchamber used in the apparatus of FIG. 1;

FIG. 8 is a front isometric view of a first embodiment of an objectholder used in the apparatus of FIG. 1;

FIG. 9 is a top isometric view of a second embodiment of an objectholder used in the apparatus of FIG. 1;

FIG. 10 is a top plan view of a third embodiment of an object holderused in the apparatus of FIG. 1;

FIG. 11 is a side plan view of the object holder of FIG. 10;

FIG. 12 is a schematic view of a third embodiment of the apparatus ofFIG. 1;

FIG. 13 is a schematic view of a fourth embodiment of the apparatus ofFIG. 1;

FIG. 14 is an exploded, perspective view of a first embodiment of apressure interface assembly utilized with the apparatus of FIG. 1;

FIG. 15 is a perspective view of the assembly of FIG. 14;

FIG. 16 is exploded, perspective view of a second embodiment of apressure interface assembly utilized with the apparatus of FIG. 1;

FIG. 17 is a perspective view of the assembly of FIG. 16;

FIG. 18 is an exploded, perspective view of a third embodiment of apressure interface assembly utilized with the apparatus of FIG. 1; and

FIG. 19 is a perspective view of the assembly of FIG. 18.

DETAILED DESCRIPTION

With reference now to the drawing figures in which like referencenumerals designate like parts throughout the disclosure, the inventionbroadly comprises methods and apparatuses for the sanitization,detoxification, disinfection, high level disinfection, or sterilizationof both the interior and exterior surfaces of an endoscope (01) orplurality of endoscopes (01) (FIG. 5) within one or more closedspace(s), closed system of space(s), or chamber(s) (herein called“sterilization chamber”) (16), as well as and, without limitation, theirsurrounding atmosphere.

This is achieved or attained by the generation and/or administration ofan “applied agent”, or mixtures of these agent(s) or substance(s), in orinto the sterilization chamber (16) in which the object(s) orendoscope(s) (01) is positioned or placed. It is more preferred, withoutlimitation, that the “applied agent” or substance is in the form of anaqueous aerosol (65) that is generated by way of one or more ultrasonicdevice(s) (19), an example of which is shown in FIG. 3 and disclosed inco-pending U.S. patent application Ser. No. 11/509,332, the entirety ofwhich is incorporate herein by reference as part of the presentspecification. It is also preferred, without limitation, that theaerosol be formed of an aqueous solution that contains a suitabledisinfecting, sanitizing or sterilizing agent(s) or substance(s) thatcontains an acidic oxidizer, such as hydrogen peroxide and peroxyaceticacid. Any chemical neutralizing agent(s) or substance(s) can also,without limitation, be used and can be in any form including, but notlimited to any liquid, gas, vapor, plasma, or aerosol.

One aspect of the present invention, is an improvement to the currentart involving an innovative pressure interface assembly (68) (FIGS.14-19) for the application of a positive or negative air/gas pressure tothe internal space, lumens, ducts, channels or fiber optic shafts ortunnels (herein called “ducts”) (08), of an object or endoscope (01), inorder to apply or administer the “applied agent” or substance(s) such asbut not limited to any gas, plasma, vapor, or aerosol, to the internalspaces and surfaces within these locations as well as the areas andsurfaces that interface or articulate with the pressure interfaceassembly (68). This innovative pressure interface assembly and itsinterface, assures that the agent(s) or substance(s) is able to reachand coat, sanitize, detoxify, disinfect, high level disinfect, orsterilize, the entirety of the internal spaces and surfaces that areinherent to various objects including, but not limited to, endoscopedesigns, diameters, and especially lengths. The assembly (68) includesan interface (02) that also assures that all of the surfaces of theobject or endoscope in contact with the interface have sufficientexposure to the aerosol (65) of an “applied agent” (20) through eitherdirect and/or indirect contact, for their sanitization, disinfection,high-level disinfection, or sterilization, depending on the agent usedand the exposure time. For example and without limitation, any absorbentinterface material may also indirectly deploy/transmit the “appliedagent” (20) that is aerosolized, to the articulated areas and surfacesby the interaction or movement of the “applied agent” (20) through theinterface (02) formed from the selected material. The present inventionalso incorporates various other improvements to the current art.

It is preferred, without limitation, that the endoscope (01) is washedaccording to the manufacturer's recommendations or methods common orprescribed in the industry or field of art, before being placed insideof the sterilization chamber (16) and the application of the “appliedagent” or substance(s) (20) to the endoscope. However, the object orendoscope can also be placed within the sterilization chamber (16) andthe washing and cleaning activities can, without limitation, take placewithin the same sterilization chamber (16) prior to the application ofthe “applied agent” (20).

According to an embodiment, any gas, vapor, plasma, aerosol, or aerosol,may be utilized or applied and be created from any chemical, mixture,compound, or anti-pathogen/toxin/fungal/sporicidal agent(s) orsubstance(s) (hereinafter ““applied agent”(s)”) (20), and it can becreated, stored, produced, or generated either inside the closed space,closed system of space, sterilization chamber (16), or inside a separatechamber (15) that is connected to the closed space, system of closedspace, or sterilization chamber (16) as shown in FIGS. 1-2 and FIGS.12-13.

According to another embodiment, the “applied agent” (20) may be in anyform including, but not limited to, a gas, vapor, plasma, aerosol, orliquid. The “applied agent” (20) in liquid form does not include anyliquid aerosols and is applied in a distinctly separate way. Inparticular, the “applied agent” (20) in liquid form is generally appliedor administered in ways including, but not limited to, being pumped,poured, flowed, or sprayed, onto, or through various internal orexternal surfaces of an endoscope.

The “applied agent” (20) may be, without limitation, one or more or anycombination of suitable compounds, mixtures, substances, or chemicals,in any concentration, number, size, or density. It is preferred, withoutlimitation, that if an aerosol (65) is utilized, it is formed generallyof droplets whose size is less than five microns. The aerosol (65) mayhave any mass concentration or density. It is further preferred, withoutlimitation, that the aerosol (65) has droplets that are of a higherrather than lower mass concentration or density.

According to an embodiment, the atmospheric pressure within thesterilization chamber, or any connecting or shared areas or atmospheres,may be any negative pressure, including a full or close to full vacuum,before or during the deployment of any “applied agent” inside of thesterilization chamber, or through any pressure interface assembly orsupply tube. This can also help to increase the efficacy of the process,and is known to those skilled in the art. Also, the “applied agent” canbe either generated inside the sterilization chamber, or any separate,but connecting area to the sterilization chamber, that may or may not becontrolled with a valve.

The amount of “applied agent” (20) that is generated and administered orapplied can vary as necessary or desired. In addition, the applicationtime and total exposure time of the “applied agent” (20) to theendoscope(s) (01) in the closed space or sterilization chamber (16) canalso vary. The level of efficacy, result, outcome, or effect that isdesired or needed, as well as the time needed to accomplish it, with theapplication of the “applied agent” (20) to any of the areas or surfaceswithin the closed space or sterilization chamber (16), pressureinterface assembly (68), or endoscope (01), including, but not limitedto, any exterior surfaces, any interface surfaces or areas, or anyinternal spaces and surfaces, can vary according to variables or anycombination of variables such as, but not limited to, the totalapplication time of the “applied agent” (20), total exposure time of thesurfaces and areas to the “applied agent” (02), temperature of the“applied agent” (20), temperature of the targeted surfaces and/or areas,relative humidity within the area that the “applied agent” is deployedor administered, flow rate and velocity of the air/gas and “appliedagent” (20) that are utilized, the amount or volume of “applied agent”(20) that is generated or produced, the amount of “applied agent” (20)that is applied or deployed to the targeted surfaces or areas, theproperties and chemical characteristics of the “applied agent” (20), theamount of positive or negative air/gas pressure that is applied to theendoscope (01) or pressure interface assembly (68) and associatedcomponents, and the concentration, number, size, and density of the“applied agent” (20). The variables can vary, without limitation, toachieve the desired or needed results and/or processing time. Othervariables may include, but are not limited to the number, shape,diameter, and length of the ducts (08), or size and number of interiorspaces inside of the object or endoscope (01), and the selection of thematerials used to form the interface (02) and the attributes of theinterface (02).

It is preferred, without limitation, that the aerosol (65) is generatedin a separate generation (production) chamber (hereinafter“generationchamber”) (15) (FIGS. 1-2) and flowed, blown, or otherwise moved intothe sterilization chamber (16) via a blower, fan, or other source ofpressurized air/gas (17), where it may then be recirculated back intothe generation chamber (15) (FIG. 2) or, to any condenser or filterknown to those skilled in the art. The respective chambers areinterconnected with piping, tubing, or conduit (18), creating a commonatmosphere or potential for a common atmosphere within the closedsystem. However, if the “applied agent” (20) is created, produced, orgenerated within the sterilization chamber (16), a blower, fan, or othersource of pressurized air/gas, can without limitation, be used todisperse the said agent(s) or substance(s) within the sterilizationchamber (16). The sterilization chamber (16) may be constructed so thatit is any shape, size, or configuration and can also, withoutlimitation, be any room, chamber, glove box, or connected system of oneor more space(s) of any size that may, without limitation, be sealed orenclosed.

The purpose of the “applied agent” (20) such as, but not limited to agas, vapor, plasma, or aerosol, in the present invention is to coat,interface, interact, envelope, or have contact with, one or morecontaminants including but not limited to toxins, bacteria, virus,fungus, spores (both fungal and bacterial), prions or other protein(s),chemicals, compounds, or other structures, within a target area(s)killing bacteria, fungus, spores, or neutralizing toxins or rendering avirus, or protein structure incapable of replication or otherwiseinterfering with the target's cellular physiology, or destroying orneutralizing the toxin and/or chemicals or chemical structures.

It is preferred in the present invention that the aerosol (65) isgenerated by one or more aerosol generating ultrasonic transducers (19)located below the surface of an aqueous “applied agent” (20) in areservoir (21), as shown in FIG. 3. Transducers (19),(22) of any design,frequency, or construction may, without limitation, be used. However,any other means to generate an aerosol, such as but not limited to, highpressure nozzle technology, (65) could potentially be used in thepresent invention, are not specifically set forth, but are known tothose skilled in the art. The reservoir (21) may be made of any suitablematerial that is unaffected by the chemical action of the “appliedagent” (20). One preferred “applied agent” (20) is a mixture of acidicoxidizing compounds including mainly hydrogen peroxide and peroxyaceticacid in an aqueous solution. Suitable materials for the reservoir (21)may include PVC, polypropylene, glass, and stainless steel, but manyother suitable materials may be used. The aerosol (65) generated byoperation of the transducers (19),(22) forms above the surface of the“applied agent” liquid (20) in the reservoir (21) and is, withoutlimitation, transferred from the basin, reservoir, and/or chamber inwhich it is created, to the space (16) to be treated by a fan, blower,or other source of pressurized air/gas (17), as will be described ingreater detail below.

The output of the transducers (19),(22) is either focused or directed toa point and/or an area near the surface of the “applied agent” (20) tocause a surface disturbance, which results in the formation of anaerosol (65) of the “applied agent” (20). This aerosol (65) is thenblown, flowed, or otherwise moved, into the contaminated area, space, ortarget area, (16) in order to coat, interface, interact, envelope, orhave contact with, contaminants including but not limited to toxins,bacteria, virus, fungus, spores (both fungal and bacterial), prions orother proteins, chemicals, compounds, or other structures, within atarget area(s) killing the bacteria, fungus, and spores, neutralizingthe toxins, or rendering the virus, or protein structure incapable ofreplication or otherwise interfering with the target's cellularphysiology, or destroying or neutralizing the toxin and/or chemicals orchemical structures. The aerosol (65) droplets are of a defined sizedistribution of less than, but not limited to, 10 microns in diameter,allowing them to behave like a gas due to Brownian movement anddiffusion. This enables the droplets to penetrate small cracks andcrevices, and apply thin films on surfaces if desired. In addition, theaerosol (65) may effectively reach and disinfect, detoxify, high leveldisinfect/sterilize, areas of contamination and areas of otherwiselimited accessibility. Each transducer (19),(22) used in this apparatusand method is preferably, without limitation, made from leadzirconate-titanate-four (PZT-4), or other suitable piezoelectricmaterials.

The present invention can include, but is not limited to, the electronicequipment mentioned in U.S. Pat. Nos. 5,878,355 and 6,102,992, whicheach are incorporated by reference herein in their entirety. A variablefrequency oscillator is used to generate a high frequency sine or squarewave. A preferred oscillator is a digital function generator/countercapable of producing sine, square, triangle, pulse and ramp waveforms.The unit has an adjustable frequency range from 0.001 hertz to 10megahertz in seven ranges. It has variable output amplitude from 5 my to500 Vp-p, variable symmetry/duty cycle from 5% to 95% in the ramp orpulse mode, continuous or externally controlled outputs. A D.C. offsetbetween −10 v to +10 v can be added to any of the output waveforms. Acontinuous wave power amplifier amplifies the wave generated by theoscillator. The preferred amplifier is a solid-state amplifier with afrequency response from 0.001 hertz to 10 megahertz. It provides up to2500 watts of linear power with low harmonic and intermodulationdistortion, however the number of watts could also be increased in orderto provide enough power to drive the desired number of transducers(19),(22).

The amplified signal from the amplifier is used to drive one or aplurality of transducer(s) (19),(22), where each transducer in thepresent invention is operated at a frequency range between 0.001 to 10.0megahertz. In addition, each transducer (19),(22) has a resonantfrequency between 0.001 and 10.0 megahertz.

Referring to FIG. 3, there is shown an aerosol generator (15) to whichthe teachings of the present invention may be applied and used. Areservoir (21) contains a volume of “applied agent” (20), the level ofwhich is controlled by a weir gate (23) operatively associated with asupply pump (24) and line (25) to maintain the level of the “appliedagent” (20) at a preferred level above the transducers (19),(22) mountedon the bottom wall of the reservoir. The “applied agent” can vary intemperature when it is applied, however it has been found that theefficiency of aerosol generation is enhanced by heating the liquid“applied agent” (20) to at least 20° F. above ambient, but preferably toat least about 80° F. A heater element (26) mounted in the liquid agentsupply sump (27) may be used for this purpose. The aerosolized (65)“applied agent” (20) is delivered to the space to be treated via an exitorifice (28) in one wall of the reservoir to which suitable piping ortubing (not shown) is attached for delivery. A heater element(s) (29)may, without limitation, be attached either to the exit orifice (28) oranywhere between the aerosol generator and the sterilization chamber astaught in prior art. This means for heating is intended to heat theaerosol to various temperatures as it is removed from the aerosolgenerator or before it reaches the closed space or sterilization chamber(16). A blower, fan, or other source of pressurized air (17) generatesthe air/gas flow necessary to deliver the aerosol (65), all in a mannerwell known in the art. As shown in FIG. 12, a return path of suitablepiping or tubing (18) may also, without limitation, connect the area orsterilization chamber (16) in which the aerosol (65) is applied back tothe air/gas intake of the blower (17) in order to create a closed systemor common atmosphere of air/gas in order to prevent positive air/gaspressure from building in the sterilization chamber (16).

A means to radiate heat (30) may also, without limitation, be providedor otherwise operatively coupled to and/or about the outlet(s) of thesterilization chamber (16), or anywhere along the return path of therecirculated air/gas (31) and aerosol before it reenters the aerosolgenerator (15), in the present invention. This is shown in FIG. 12. Theradiated heat provides the added benefit of heating the returningair/gas (31) and aerosol droplets to various temperatures. This may,without limitation, further reduce the diameter of the aerosol droplets(65) so as to lessen the possibility of an impact with droplets (65)within the aerosol generator (15) that would result in the coalescenceand/or creation of larger droplets. The heat can vary in its temperatureand intensity.

A means to heat the floor and/or bottom area (32), of the sterilizationchamber (16) may also, without limitation, be added to the presentinvention as shown in FIG. 6. A heated plate (32) placed on the floor ofthe sterilization chamber (16) may also be positioned in this location.The thermal, or convective forces emitted from the heated floor orbottom area (32) of the chamber is intended, without limitation, to bothrepel any aerosol droplets as they settle, and delay their downward pathof travel. An added benefit is that any droplets that do touch or comein close proximity to the heated floor (32) can be turned to vapor orgain additional thermal energy, which can contribute to the efficacy ofthe process. The means (32) to heat the floor can, without limitation,vary in its temperature and intensity.

One or more polymer glove(s) or fingers(s) (33) may be incorporated intothe system of closed space, and/or the sterilization chamber (16) or anarea that can access these spaces, as shown in FIG. 7. They can have abroad similarity in purpose, design, and concept as gloves(s) orfinger(s) (33) that are commonly found in laboratory or industrial gloveboxes. They can enable an operator to handle the endoscope (01) withinthe sterilization chamber (16) both before and after the cleaning cycleand related activities have occurred. In addition, the operator can usethe glove(s) or finger(s) (33) to handle and place the endoscope (01)into packaging such as but not limited to trays, pouches, bags, or othermeans to otherwise hold the endoscope (01), and then sealing thepackaging so as to keep the packaged endoscope (01) free fromcontamination or to insure that its properties or characteristics areunaltered. This allows the operator to handle and package the sanitized,detoxified, disinfected, high level disinfected, sterilized, orotherwise cleaned endoscope (01) without having to expose the endoscope(01) to the outside environment and risk contamination.

The endoscope (01) that is placed within the sterilization chamber (16)can be packaged before or after the present invention has completed itsoperational cycle for the sanitization, detoxification, disinfection,high level disinfection, or sterilization, of the objects, with methods,equipment, and materials which are not specifically set forth, but knownto those skilled in the art. This can include packaging methods,equipment, and materials used in industries including but not limited tomedical devices, and medical related products.

According to an embodiment, any package (not shown) containing one ormore of any objects (not shown) can also be processed in the presentinvention, for the sanitization, detoxification, disinfection, highlevel disinfection, or sterilization, of the interior of the package aswell as its contents. The package may or may not be connected to thepressure interface assembly 68). It is preferred, without limitation,that the package is constructed of polymer, and it has at least one ormore sides that is constructed from materials such as, but not limitedto, Tyvek or a similar type of material, glassine, or any type ofpermeable or semi-permeable material. The packaging materials can bemade from any material or combination of materials, and be of anythickness or polarity. It is preferred, without limitation, that thepackage is constructed in the form of a flexible pouch containing atleast one wall that is constructed from a flexible layer of Tyvek whoseconstruction and thickness is commonly used in the medical industry andis known to those skilled in the art. The package may be, withoutlimitation, subjected to any combination and sequence of the followingoperational parameters such as: (a) Any temperature before exposure tothe “applied agent” (b) Any negative atmospheric pressure or vacuumbefore or during the deployment of any “applied agent” inside of thesterilization chamber (16), (c) any exposure times of the package to the“applied agent”, (d) any amount of “applied agent” (e) any temperatureduring exposure to the “applied agent”, (f) any positive atmosphericpressure before, during, or after the deployment of any “applied agent”inside of the sterilization chamber (16), (g) any temperature afterexposure to the “applied agent”, (h) any temperature and pressure to drythe contents, interior, and exterior of the package, and (i) any dryingtime.

As also shown in FIG. 7, one or more chemical exposure indicator(s),and/or biological indicator(s) (hereinafter “indicator”) (34) can bemounted, held, hung, positioned, or placed, anywhere inside of theclosed space or sterilization chamber (16). The position of theindicator(s) (43) can vary both vertically and horizontally with respectto the object(s) in the closed space or sterilization chamber (16). Theindicators (34) provide a means for assuring that proper sanitization,detoxification, disinfection, high level disinfection, or sterilizationhas occurred for the object (01) and/or the closed space orsterilization chamber (16). A detailed description of the constructionand operation of suitable chemical exposure indicator(s) and/orbiological indicator(s) (34) is not specifically set forth, but is knownto those skilled in the art.

Referring again to FIG. 12, one or more means (35) known to thoseskilled in the art may, without limitation, be operably connected tovarious components of the present invention to effectively close off,seal, or separate, the closed space or sterilization chamber(s) (16)from the “applied agent” (20) generation chamber(s) (15), and/or thetubes, ducting, channels, tunnels, etc. (18), that connect the “appliedagent” (20) generator(s) (15) to the closed space or sterilizationchamber(s) (16), at any time including, but not limited to, before orduring any washing, cleaning, drying, or other processing activities ofthe endoscope (01). Referring to FIGS. 4, 5, and 12, the means (35) can,without limitation, be any cap or separating device implemented foroperably sealing off various portions of the apparatus of the presentinvention including: a) any air/gas outlet (36) or air/gas inlet (37),or anywhere along the path, for any air/gas or “applied agent” (20) thatis flowed through the pressure interface assembly (68); b) any inboundfresh air/gas inlet (38); c) any outbound or exhaust air/gas outlet(39); d) any opening, or inlet or outlet, to/from the sterilizationchamber (16), including but not limited to, any air/gas inlet (70) orair/gas outlet (72) to/from the sterilization chamber (16); e) any othertubes, ducting, channels, tunnels, or other parts or components, etc.,that would need, or be desired, to have a controlled connection oraccess, to the pressure interface assembly (68), sterilization chamber(16), or other connected or potentially connected closed space or systemof closed space. The said means (35) can be a door, flap, valve, lid,panel, or other physical means (herein called “valve”) (35), to containthe chemicals, liquids, vapor, gases, or other substances used in thewashing and/or processing activities, within the closed space orsterilization chamber(s). The said means is constructed of any suitablematerial that is unaffected by the chemical action of the agents orsubstances used for the washing, cleaning, or processing activities, orthe anti-pathogen/toxin/fungal/sporicidal agent(s) or substance(s) thatis applied or administered. Referring to FIGS. 12-13, certain valves,covers, doors, flaps or other means known to those skilled in the art(herein called “system valve”) (40) may be effectively used during theapplication or administration of the “applied agent” (20) in thesterilization chamber (16). Each system valve (40) can be actuated,closed, or operated to effectively stop the transfer, flow, or movementof air/gas or “applied agent” (20) through the inbound fresh air/gasinlet (38), the outbound or exhaust air/gas outlet (39), and/or thetubes, ducting, channels, tunnels, etc. (18), that connect the freshair/gas inlet (38) or exhaust air/gas outlet (39) to the closed systemof space or sterilization chamber (16). The various valves (35),(40) inthe present invention can be actuated, opened, or operated so that anysubstances may flow through the valves (35),(40) when desired or needed.In addition, the various valves (35),(40) can be effectively utilized atvarious times to allow the fresh air/gas from outside of the presentinvention to flow through, without limitation, the inbound fresh air/gasinlet (38), the air/gas inlet(s) (37) for the air/gas that is flowedthrough the pressure interface assembly (68), the “applied agent”generator (15), the outbound or exhaust air/gas outlet (39), and/or thetubes, ducting, channels, tunnels, etc. (18), that connect the freshair/gas inlet (38) or exhaust air/gas outlet (39) to the closed systemof space or sterilization chamber (16). Referring to FIG. 12, anadditional valve (42) can be utilized to separate the flow of inboundfresh air/gas from the outbound air, gas, or “applied agent” (20) asthey are circulated through and from the closed system of space orsterilization chamber (16) and exhausted out of the present inventionand into the external environment. The various valves (35),(40),(42) aredesigned, operationally controlled whether manually or automatically,and operationally sealed in a manner that is not specifically set forth,but known to those skilled in the art. This includes the possibleoperation, command, and control of the valves (35),(40),(42) via anelectronic or electrical means.

Referring to FIGS. 4-5 and FIGS. 12-13, The sanitization,detoxification, disinfection, high level disinfection, or sterilizationof both the internal and external surfaces of an endoscope (01) beginswith placing it in the closed space or sterilization chamber (16). Theendoscope (01) can, without limitation, be washed, cleaned, rinsed,and/or processed after it is placed in the sterilization chamber (16),but prior to the application of the “applied agent” (20). It ispreferred, without limitation, that the object or endoscope (01) iswashed, cleaned, rinsed, and/or dried and processed before it is placedin the sterilization chamber (16). In either case, the washing,cleaning, rinsing, drying, and/or processing is performed according tomethods that are common in the industry in which the object or endoscope(01) is used, and/or according to the recommendations of the object orendoscope's (01) manufacturer. A means for washing, cleaning, rinsing,and/or processing the object(s), such as endoscopes (01), within thesterilization chamber (16), which results in the endoscope (01) beingclean, and/or removing contamination such as, but not limited to, blood,saliva, mucous, feces, or tissue, before the application of an “appliedagent” (20), may also, without limitation, be added in the presentinvention and is known to those skilled in the art. After placing theendoscope (01) in the sterilization chamber (16), and the washing,cleaning, and/or processing steps are completed, if they were performed,an “applied agent” (20) such as, but not limited to, any gas, plasma,vapor, or aerosol, is generated and administered, moved, or blown intothe closed space or sterilization chamber (16), covering all of theexternal and possibly the internal surfaces over time. Despite theability of small droplets and gases to penetrate hard to reach places,it is still difficult and time consuming to disinfect or sterilize theinterior surfaces of objects or instruments like endoscopes (01) due tothe length and small diameter of features such as, but not limited to,their lumens or ducts (08), and their general construction. However, byusing positive or negative air/gas pressure to move the “applied agent”(20) through these hard to reach areas, they can without limitation, beeasily and quickly, sanitized, detoxified, disinfected, high leveldisinfected, or sterilized. The “applied agent” (20) may be pushed orpulled through the endoscope (01) by using the supplied positive ornegative air/gas pressure for all endoscope (01) related applicationsincluding, but not limited to, all uses related to the pressureinterface assembly (68) as well as all other general endoscope (01)interfaces already known to those skilled in the art. In addition, the“applied agent” (20) may, without limitation, be administered ordeployed into the sterilization chamber (16) where it is then pulledinto and through the endoscope (01) that is positioned within thesterilization chamber (16).

Referring now to FIGS. 14 and 15, one or more open ends or openings ofan endoscope (01) are interfaced with one or more pressure interfaceassembly(s) (68). The open end of an endoscope (01), can include, but isnot limited to, the end of the endoscope (01) where the various ducts(08), or other ports end, exit, or are made visible or accessible. Thisunique and innovative pressure interface assembly (68) has partsincluding, but not limited to, a coupling (04), and an interface orinterface material (02) combination. The coupling (04) can have one ormore ports or other means (hereinafter “main port”) (06) for attachingone or more tubes, hose, pipes, duct, tunnels, conduit, or other means(herein called “supply tube”) (11) that can supply air, gas, liquid, orthe “applied agent” (20) under positive or negative pressure, to thevarious spaces and surfaces of the pressure interface assembly (68) andendoscope (01), including without limitation, their interfacing surfacesand internal spaces and surfaces, under positive or negative pressure.The supply tube (11) can be any size. The main port (06) can, withoutlimitation, connect the space within the pressure interface assembly(68) to the space within the supply tube (11) so that the spaces becomeconnected.

Looking at FIGS. 4 and 5, the supply tube (11) can, without limitation,be effectively connected anywhere to the generation chamber (15) or anyother effective area, which is in turn connected to any source ofpressurized air/gas or vacuum. The pressure interface assembly (68)allows for any aerosol (65), air/gas, liquid, or “applied agent” (20) tobe driven, pushed, or pulled through places such as, but not limited to,both the internal space and/or ducts (08), of the endoscope (01), aswell as through the interface material (02) and/or interface location,for purposes including, but not limited to, rinsing the endoscope (01),drying the endoscope (01), or the sanitization, detoxification,disinfection, high level disinfection, or sterilization of these areasand their respective surfaces. It is preferred, without limitation, thatthe pressure interface assembly (68) is utilized inside of thesterilization chamber (16), but it could also be used outside of thesterilization chamber (16) in applications not specifically set forthbut are known to those skilled in the art.

The supply of a positive or negative air/gas pressure to the pressureinterface assembly (68) may originate from any vacuum pump, air/gaspump, pressurized air source, fan, or blower (44),(17). The air/gaspressure can vary depending on the situation and particular applicationand can serve several functions. First, the positive and/or negativeair/gas pressure can, without limitation, be applied to the pressureinterface assembly (68) at the beginning and/or end of the sanitization,detoxification, disinfection, high-level disinfection, or sterilizationcycle, in order to move air/gas or dry and/or heated air through theinterior space of the endoscope (01). This will remove any moisture ifit is still present in these areas.

Referring now to FIGS. 12 and 13, one or more heating element(s)(29),(52) placed in the air stream before or after the pressureinterface assembly (68) can provide the heated air (referenced Rosdahlet al. pg 3 Col. 123-127). It is preferred, without limitation, that airfrom outside of the sterilization chamber (16) that is pulled, drawn,pushed, or otherwise moved into the sterilization chamber (16) and/orthe endoscope (01) be first filtered before its entry into thesterilization chamber (16) and/or endoscope with one or more highefficiency filter (53) such as, but not limited to, a HEPA filter orother filter that is known to those skilled in the art or is acceptablein the industry in which it is used. The air/gas stream may also,without limitation, be filtered by one or more filters (54) before itexits from the sterilization chamber (16); and the filter is known tothose skilled in the art or its use is acceptable in the industry inwhich it is used. The air can, without limitation, be heated within thesterilization chamber (16) and/or before its entry into thesterilization chamber (16) from areas including, but not limited to, theoutside atmosphere, or the atmosphere that surrounds the outside of thesterilization chamber (16), in order to help dry the endoscope (01) atthe desired time or stage during processing.

Also, the positive air/gas pressure or negative air/gas pressure isintended to move the “applied agent” (20) through the interior space ofthe endoscope (01). It is preferred, without limitation, that, as shownin FIG. 4, if a negative air/gas pressure is supplied to the coupling(04) that is interfaced or attached to the endoscope (01), a pressuredifferential is established. This results in the flow of air/gas and the“applied agent” (20) from areas such as, but not limited to, thesterilization chamber (16), through “both” the interface material (02)and internal space within the endoscope (01), and into the coupling(04). Once in the coupling (04), the air/gas and the “applied agent”(20) flows into the attached pipes, tubes, conduits, etc. (11),(118),where it is eventually vented back into the sterilization chamber (16),or through a filter (54) and into the outside environment.

The “applied agent” (20) can, without limitation, flow into the coupling(04) under positive air/gas pressure, as shown in FIG. 5. It ispreferred, without limitation, that in this situation, the air/gas and“applied agent” (20) is pulled from the sterilization chamber (16), orchamber where the “applied agent” is generated (15), and flowed into thecoupling (04) via the attached pipes, tubes, conduits, etc. (18),(11).It is then flowed “both” out of the interface material (02) and throughthe internal space within the endoscope (01), and into the sterilizationchamber (16). The “applied agent” (20) in this case, can also beseparately delivered into the sterilization chamber (16), if it isgenerated in a chamber (15) separated from the sterilization chamber(16).

Without limitation, the apparatuses and methods can be used or takeplace in any type of rigid, semi-rigid, flexible container, or package(herein called “container”), and the container can function as thesterilization chamber (16). The container (16) can, without limitation,have the pressure interface assembly (68) or coupling (04) integratedinto its design or construction. The container (16) can, withoutlimitation, be designed so that it can be sealed and function aseffective packaging or medical quality packaging after completion of theprocessing steps in a manner that meets or exceeds industry andregulatory standards.

Referring to FIG. 4-5, 14-16, the coupling (04) can be constructed fromvarious materials such as, but not limited to, stainless steel, glass,polymer, polyolefin, cellulose, or even natural or manufactured fibersthat are either coated or uncoated. The coupling (04) can, withoutlimitation, be constructed from one or more polymers that meets orexceeds industry and regulatory standards. It is preferred withoutlimitation, that the coupling (04) is constructed from one or morepolymers that can include, but is not limited to PVC, polycarbonate,polypropylene, and HDPE. The coupling (04) surfaces can, withoutlimitation, be electrically or electrostatically charged in order toattract the “applied agent” (20). It is preferred, without limitation,that the materials used to construct the coupling (04) may be rigid,semi-rigid, or flexible. A flexible polymer or tube roll is one exampleof a flexible material that could be used. The pressure interfaceassembly (68) can be designed and constructed for single or multipleuses. It is preferred, without limitation, that the coupling (04) isdesigned so that one end is able to fit over an end of an endoscope(01), and the other end of the coupling (04) is substantially closed.The coupling (04) can, without limitation, be designed so that one endis able to fit over an end of an endoscope (01), and the other end ofthe coupling (04) is designed to interface or connect with a supply tube(11) or other means to connect the coupling (04) to a source of negativeor positive air/gas pressure in a suitable manner. For example, one endof the coupling (04) can be, without limitation, open and its exteriorsurface can have a hose barb, or a portion of its exterior surface canbe molded into a barb of sufficient size to securelyinterface/articulate it with a supply tube (11). The end of the coupling(04) that is designed to fit over an end of an endoscope (01), can havean opening of various sizes and shapes. This opening can control thenegative or positive air/gas flow in or out of the coupling (04).

One or more main ports (06) or means to connect the coupling (04) with asupply of positive and/or negative air/gas pressure that is used todrive, push, or pull the “applied agent” (20) through both the ducts(08) of the endoscope and the interface (02), can be located on theclosed end or “air/gas pressure interfacing end” of the coupling (04).This main port(s) (06) may be connected to a positive or negativeair/gas pressure supply tube (11) in order to create a positive air/gasor negative air/gas pressure within the coupling (04). In the context ofthe present invention, “tube” or “tubing” includes pipes, ducts,conduits, tunnels, and the like.

One or more chemical contact or biological indicators (hereinafter“indicator(s)”) (05) of any size type or construction may be mounted,held, hung, positioned, or placed, anywhere inside of the pressureinterface assembly (68). The pressure interface assembly (68) isdesigned for the addition as well as possible removal of theseaccessories. The indicator (05) provides a means for communicating orassuring that proper sanitization, detoxification, disinfection, highlevel disinfection, or sterilization has occurred within the endoscopeand/or the pressure interface assembly. A detailed description of theindicator (05) is not specifically set forth, but is known to thoseskilled in the art.

The internal dimensions of the coupling (04) help provide for aninterface/articulation between the endoscope (01), the interface orinterface material (02) (if it is used), and the coupling (04), thatpermits the creation of at least a minimum working positive or negativeair/gas pressure inside of the coupling (04) and endoscope (01), butstill allows “applied agent” (20) to penetrate and sanitize, detoxify,disinfect, high level disinfect, or sterilize the areas and surfacesthat interface/articulate or are between the endoscope (01) and theinterface material (02) (if it is used), or the coupling (04). Incertain circumstances, the inner diameter of the coupling (04) inaddition to its thickness can contribute to the performance of theinterface (02). This can include but is not limited to, coupling (04)designs where the part of the coupling (04) that interfaces with theendoscope (01) is constructed from materials that are flexible and mayor may not have elastic properties. More specifically, the insidedimensions and thickness of the coupling (04) can change in order toaccommodate various variables, including, but not limited to, pressures,temperatures, sizing, shape, fit, interface integrity, interfaceefficiency, thickness of the interface, as well as other variables toachieve efficacy with the process. The coupling (04) may not even touchthe exterior or internal surfaces of the endoscope (01).

Referring to FIGS. 14-19, the coupling (04) is preferably used incombination with an interface (02) to interface/articulate with theexternal circumference or external surfaces of the endoscope (01). Inaddition, it is preferred that the interface (02) is positioned betweenthe coupling (04) and the endoscope (01).

The interface (02) can be, without limitation, porous, and/or permeable,and is constructed from materials that can provide effective performanceand the desired level of efficacy for the process. The interface (02)can be, without limitation, constructed of one or more layers ofmaterial. The interface (02) may also have absorbent characteristics toimprove its efficacy and performance. The interface (02) is intended,without limitation, in the present invention to allow the air/gas andthe “applied agent” (20) to move or flow through the interface layer ata controlled, but effectual rate, so that at least a minimum workingpositive or negative air/gas pressure is created or established insideof the coupling (04) and endoscope (01). This minimum working positiveor negative air/gas pressure that is created or established inside ofthe coupling (04) and endoscope (01), moves or otherwise results in themovement or flow of the “applied agent” (20) through places such as, butnot limited to, the interior space, or ducts (08), of the endoscope (01)and results in the sanitization, detoxification, disinfection, highlevel disinfection, or sterilization of these surfaces and areas. Theminimum working positive or negative air/gas pressure that is created orestablished inside of the coupling (04) and endoscope (01), moves orotherwise results in the movement or flow of the “applied agent” (20)through the interface (02) and areas of interface/articulation betweenthe interface (02) and endoscope (01), and results in the areas andsurfaces under the interface (02) to be exposed to, and acted upon, bythe “applied agent” (20) in order to achieve the desired level ofsanitization, detoxification, disinfection, high level disinfection, orsterilization. The interface (02) can include, but is not limited tocloth, gauze, manufactured fibers, synthetic fibers, natural fibers ormaterials, cellulose, polymer, polyolefin, glass, metal, ceramic,carbon, combinations of these materials, or other materials know in theart. The interface (02) can be coated with chemicals, materials, orsubstances including, but not limited to, polymer(s), polyolefin, wax,lipid, oil, enamel, paint, carbon, metal, combinations of thesematerials, or other materials known in the art. The interface material(02) as well as the coupling (04) surfaces can be electrically orelectrostatically charged or uncharged in order to attract the “appliedagent”. The electrostatic potential or polarity of the various materialsas well as the “applied agent” (20) can, without limitation, vary.Interface materials (02) that are developed in the future may beutilized to improve the efficacy of the design or its application tocertain objects, endoscopes (01), or devices. The interface (02) and itseffectiveness can vary with variables including but not limited to, itssize, width, surface area, shape, fit, thickness, density, hardness,elasticity, flow rate, porosity, permeability, evenness of air/gas flow,mechanical properties, physical properties, and other variables known tothose skilled in the art. However, the effectiveness and efficacy ofeach interface (02) can increase with attributes such as, but notlimited to, the uniformity of these variables throughout the interfacethat is used. The interface (02), coupling (04) and endoscope (01), canbe planned, manufactured, or formed, to assure the proper placement,fit, or function of these components. This means can include, but is notlimited to, closing or tapering the ends of the interface (02) tovarious amounts or increments, the presence of ribbings, pegs, grooves,studs, or clips, or other means known to those skilled in the art, thatare indented or protrude from components including, but not limited to,the interface (02), coupling (04) and/or endoscope (01), so that theinterface (02) can interlock or have a controlled or guidedarticulation/interface with the coupling (04) and/or object or endoscope(01). The interface (02) may be connected to the coupling (04), orendoscope (01) in various ways that include, but is not limited to,welding, forming, molding, bonding, adhering, gluing, laminating, orcementing. The performance of the interface (02) or the pressureinterface assembly (68) may, without limitation, be improved by welding,forming, molding, bonding, adhering, gluing, laminating, or cementing,one or more layers of material with attributes such as, but not limitedto any, width, surface area, shape, thickness, density, hardness,elasticity, flow rate, porosity, permeability, evenness of air/gas flow,mechanical properties, or physical properties, between the interface(02) and the coupling (04), or between the endoscope (01) and theinterface (02). It is preferred, without limitation, that the materialis pliable. The coupling (04) can also be constructed from, or otherwisebe, the interface material (02) or interface layer (02) and function asthe interface (02), which negates the use of a separate interface layer(02). This represents the pressure interface assembly (68) in itssimplest form. In this case, the coupling (04) is designed andconstructed so that it incorporates the purpose, performance, traits,attributes, and characteristics of both the interface (02) and thecoupling (04). Everything pertaining and related to the interface (02),coupling (04), and exertion of pressure on these materials, in thepresent invention also pertains to this particular design/construction.

The performance of the interface (02) is also impacted by theapplication, existence, and/or control of a pseudo constant or constant,and effectively distributed, pressure exerted on the interface (02)(herein called “exerted pressure”) as it contacts the endoscope (01).This exerted pressure provides, without limitation, an effectivedistribution of flow of the “applied agent” (20) through the interface(02) and areas of interface/articulation between the interface (02) andendoscope (01), and results in the areas and surfaces under theinterface (02) and surfaces of the endoscope (01) thatinterface/articulate with the interface material (02), to be exposed toand acted upon, by the “applied agent” (20), in order to achieve thedesired level of sanitization, detoxification, disinfection, high leveldisinfection, or sterilization. The application, existence, and/orcontrol of a constant or relatively constant, and effectivelydistributed, pressure exerted on the interface (02) as it contacts theendoscope (01), can also, without limitation, be sufficient to hold theendoscope (01) if it is suspended in the sterilization chamber (16) viathe pressure interface assembly (68). The weight of the endoscope (01)and/or pressure interface assembly (68) can provide at least the minimumpressure/force needed to form and/or establish a usable and efficaciousinterface/articulation, and this can, without limitation, beaccomplished in a manner known in the art.

It is preferred in the present invention that the exerted pressure isnot only effective, but it is evenly distributed. In addition, thisexerted pressure can also affect the balance of flow of the “appliedagent” (20) through the interface (02), as well as the interior space orducts (08) of the endoscope (01). It is preferred in the presentinvention that the flow of air/gas and “applied agent” (20) through theinterface (02), as well as the interior space or ducts (08) of theendoscope (01), is adjusted so that a desired level of sanitization,detoxification, disinfection, high level disinfection, or sterilizationcan be achieved. The exerted pressure can vary due to variables relatedto the interface (02), including but not limited to its, size, width,surface area, shape, fit, thickness, density, hardness, elasticity,mechanical properties, physical properties, and other variables known tothose skilled in the art. The exerted pressure can also vary to controlvariables associated with the air/gas and “applied agent” (20),including but not limited to, flow rate, air/gas flow and pressure,permeability, and evenness of flow through the interface material (02),and balance of flow through both the interface material (02) and theinterior space or ducts (08) of the endoscope (01). The exerted pressurecan vary depending on the amount of force that is exerted on theinterface material (02), and the amount of surface area of the interfacematerial (02) that receives that force (force per unit area).

The effective pressure that is exerted on the interface (02) can resultfrom the articulation/interface of the coupling (04), interface (02),and endoscope (01). This can be accomplished by ways including, but notlimited to, adjusting the designs, dimensions, and properties, of thecoupling (04), interface (02), and endoscope (01), to create a loose ortight fit and/or a weak or strong friction fit, with the interface (02)and the endoscope (01). It can be accomplished through the use ofadditional means to exert pressure around the coupling (04), interface(02) and endoscope (01) in order to create an effectivearticulation/interface, and includes but is not limited to positioning aclamp over or around the coupling (04) and applying pressure to thecoupling (04), interface (02), and endoscope (01), which creates aneffective articulation/interface. It can also be accomplished byutilizing a coupling (04) where at least the part or area of thecoupling (04) that interfaces/articulates with the endoscope (01) isconstructed from material that is flexible, and may or may not haveelastic properties, and one or more parts or areas of this coupling (04)that interface/articulate with the endoscope (01) have dimensions, aninner diameter or inner dimensions, and width, so that an effectivepressure is exerted on the interface material (02) when the coupling(04) is interfaced/articulated with the endoscope (01). As shown inFIGS. 16 and 17, this can include, but is not limited to, a coupling(04) that is completely or partially constructed from a flexiblematerial (12),(14) and/or one or more flexible rings (13) that areeither built into the flexible material (12),(14) or positioned outsideand around the coupling's flexible wall material (12),(14). For example,and without limitation, an effective or sufficient interface (02) can beprovided by, without limitation, one or more rings (13) that fit over,and are utilized to apply an effective or sufficient force or pressureto, the coupling (04), interface (02), and endoscope (01). Variousattributes including, but not limited to, the dimensions, thickness,interior dimensions or interior diameter, and width, of the rings (13)have tolerances so that the rings (13) exert effective pressure on thecoupling (04), interface (02), and endoscope (01), when the pressureinterface assembly (68) interfaces/articulates with the endoscope (01).This can also include, but is not limited to, a coupling (04) that isconstructed from a rigid or semi-rigid polymer and one or more rings(13) are built into the coupling's (04) interior wall where they caninterface/articulate with the interface (02), and endoscope (01).Various attributes including, but not limited to, the dimensions,thickness, interior dimensions or interior diameter, and width, of therings (13) have tolerances so that the rings (13) exert effectivepressure on the coupling (04), interface (02), and endoscope (01), whenthe pressure interface assembly (68) interfaces/articulates with theendoscope (01).

According to an embodiment, one or more encircling geometric shapes orrings (not shown) can also be added to the exterior of an endoscope (01)and/or to the endoscope (01) interfacing/articulating surfaces of thepressure interface assembly (68). Without limitation, these encirclinggeometric shapes or rings can protrude outward or inward, and can becreated without limitation by cutting, carving, engraving, molding,thermoforming, or laminating, gluing, cementing, adhering, or otherwisebeing attached, to the pressure interface assembly (68). Withoutlimitation, the encircling geometric shapes or rings can also bepartially or fully constructed from and have the same chemical,physical, and mechanical properties of the materials that can be used toconstruct the endoscope (01), the coupling (04), and/or one or more ofthe interfaces (02) that articulates between the pressure interfaceassembly (68) and the endoscope (01), and can also be made from acombination of these different materials.

These shapes or rings can, without limitation, interact with each other,the interface material (02), the endoscope (01), the coupling (04),and/or the pressure interface assembly (68). They can be connected tothe interface material (02) in various ways that include, but are notlimited to, welding, forming, molding, bonding, adhering, gluing,laminating, or cementing, and/or they can also function as the interface(02). The encircling geometric shapes or rings can also interact orinterlock with each other to securely engage the assembly (68) with theendoscope (01). For example, without limitation, the rings can slidepast or over each other and into a static position, or be turned withina grove and lock into a static position. The interaction of theseencircling geometric shapes or rings can create at least the minimumpressure/force needed to form and/or establish an efficacious and usableinterface (02) and interface/articulation. The interaction of theseencircling geometric shapes or rings can also be used to bear the weightof the endoscope (01) if it is suspended in the sterilization chamber(16) via the pressure interface assembly (68). The weight of theendoscope (01) and/or pressure interface assembly (68), in this instancecan also provide at least the minimum pressure/force needed to formand/or establish a usable and efficacious interface (02).

Referring to FIGS. 18-19, an inflatable pillow, balloon, bladder,reservoir, or other inflatable or expandable means or material(hereinafter“balloon”) (03), can be used to exert an effective pressureon the interface material (02), as well as on the coupling (04). Varyingthe amount of exerted pressure inside of the balloon (03) can controlthe pressure that is exerted. The balloon (03) can be utilized in waysincluding, but not limited to, inserting or positioning the balloon (03)completely, or at varying positions or amounts, around the interface(02), on the side of the interface (02) that is furthest away from theendoscope (01) and closest to the interior wall of the coupling (04),and inflating the balloon (03) after the pressure interface assembly(68) is effectively positioned or has interfaced/articulated with theendoscope (01). The balloon (03) can also be positioned and effectivelyused inside of the coupling (04) wall material or on the exteriorsurfaces of the coupling (04). The size, width, thickness, inflationpressure, material of construction, and design of the balloon (03) canbe influenced by many factors including, but not limited to the negativeand positive pressure or air/gas pressure that can be exerted within thecoupling (04), the temperatures of the “applied agent” (20), the amountof pressure that is needed inside of the balloon (03) in order to applyan effective pressure on the interface (02), and the type of chemicalinteraction between substances such as, but not limited to, the “appliedagent” (20), and various materials of construction. The balloon (03) mayassume many different shapes including, but not limited to, a toroidalshape. The balloon (03) can also be constructed from, or have itsoutermost layer constructed from the interface material (02), and theballoon (03) can function as the interface (02). The balloon (03) canhave a port and/or valve (herein called “balloon port”) (07) to connectwith a source of pressurized fluid, and is inflated and deflated by wayof a means that is known to those skilled in the art. The source ofpressure can include, but is not limited to, the supply of air, gas,liquid, or foam under positive pressure. An effective pressure can alsobe created as the result of a chemical reaction inside of the balloon(03).

Parameters such as, but not limited to: a) the exerted pressure on theinterface (02); b) the positioning of the coupling (04) on or to theinterface material (02); c) the surface area of the coupling (04) thatinterfaces/articulates with the interface material (02) or endoscope(01); d) any physical, chemical, or mechanical interactions between anycomponents of the pressure interface assembly (68); d) the size, width,surface area, shape, fit, thickness, density, hardness, elasticity, flowrate, porosity, permeability, mechanical properties, physicalproperties, and other variables known to those skilled in the art,relative to various components of the pressure interface assembly (68)such as, but not limited to the interface material (02), the coupling(04), and endoscope (01); e) evenness of air/gas and “applied agent”flow (20); can all, without limitation, be varied and may help controlthe air/gas pressure differential between the outside and inside of thecoupling (04). These parameters may also vary, without limitation, tohelp control the air/gas pressure differential between the endoscope's(01) ducts (08) and the outside and inside of the coupling (04). This inturn controls the balance of the “applied agent” (20) flow through theinterface (02) and any interfaced/articulated areas verses the interiorspace or ducts (08) of the endoscope (01). These variables are optimizedfor each endoscope (01) configuration based on the outside diameter ofthe endoscope (01), and the number, diameter, area, and length of theinterior spaces or ducts (08), of the endoscope (01).

Referring to FIG. 4, for applications involving the movement of an“applied agent” (20), in form including but not limited to any gas,plasma, vapor, and/or aerosol, through the endoscope (01) with negativeair/gas pressure (vacuum), the endoscope (01) is placed within theclosed space or sterilization chamber (16), or other area within theclosed system, and the pressure interface assembly (68) is interfacedwith an end of the endoscope (01). The “applied agent” (20) is thengenerated and/or administered or applied, filling the closed space orsterilization chamber (16). The “applied agent” (20) that is in thesterilization chamber (16) is then pulled through one end of theendoscope (01), through its interior space or ducts (08) via a negativeair/gas pressure (vacuum) that is created in the coupling (04). Thenegative air/gas pressure can vary. The “applied agent” (20) is then,without limitation, pulled through any supply tube (11) and is then,without limitation, vented into an area (36) either back into thesterilization chamber (16), or other area within the closed system. Thevacuum is generated by one or more, without limitation, air/gas pump,vacuum pump, venturi apparatus, blower, fan, or other means (44),(17)that can create a negative air/gas pressure (vacuum) within the pressureinterface assembly (68). The “applied agent” (20) that is pulled withvacuum can also vent into the outside environment after being filtered,if filtering is necessary. If the “applied agent” (20) is vented intothe outside environment, a means to provide equalization in air/gaspressure between the closed system and the outside environment isprovided and the movement of the air/gas is filtered. The resultingprocess is the sanitization, detoxification, disinfection, high leveldisinfection, or sterilization, of both the exterior of the endoscope(01) and its interior space or ducts (08).

Referring to FIG. 5, alternatively, for applications involving themovement of an “applied agent” (20) in the form including but notlimited to any gas, plasma, vapor, and/or aerosol, through the object orendoscope (01) with positive air/gas pressure, the endoscope (01) isplaced within the closed space or sterilization chamber (16), or otherarea within the closed system, and the pressure interface assembly (68)is interfaced with an end of the object or endoscope (01). The “appliedagent” (20) is then generated and/or administered or applied, fillingthe closed space or sterilization chamber (16). The “applied agent” (20)that is in the closed space or chamber (16), or other area within theclosed system, is then, without limitation, pulled through one end (37)of a tube (18) and forced out the other end of the same tube or anyother connected tube(s), into the supply tube (11), under positiveair/gas pressure, and then into the coupling (04) thatinterfaces/articulates with the endoscope (01), and then into andthrough the interior space or ducts (08) of the endoscope (01) where itis then vented back into the closed space, sterilization chamber (16),or other area within the closed system. The positive air/gas pressure isgenerated by one or more air/gas pump, vacuum pump, blower, fan, orother means (44),(17) that can create a positive air/gas pressure withinthe pressure interface assembly (68). The positive air/gas pressure canvary. The “applied agent” (20) in this case can also be pulled from asource that is separate from the sterilization chamber (16). The resultof the whole process is the sanitization, detoxification, disinfection,high level disinfection, or sterilization, of both the exterior of theendoscope and its interior space, lumen(s), and/or channels.

The positive or negative air/gas pressure can also be supplied to thepressure interface assembly (68) and the interfaced/coupled orarticulated object or endoscope (01), by one or more air/gas pump,vacuum pump, blower, fan, or other means (44),(17), at different timesduring the sanitization, detoxification, disinfection, high leveldisinfection, or sterilization cycle. For example, this can beperformed, without limitation, either before or after the “appliedagent” (20) is generated and/or administered or applied. The purpose isto move, without limitation, fresh filtered or non-filtered air/gasand/or dry air/gas through the interior space or ducts (08) of theendoscope (01), which removes any moisture, liquid, and/or “appliedagent” (20) that is present, or cause the moisture, liquid, agent,“applied agent” (20) or substance that is present to be removed orevaporated.

One challenge with the application of an “applied agent” (20) by aerosolor other means, is that of obtaining full coverage on all surfaces ofthe endoscope (01) or the targeted space, areas, or surfaces. This isespecially true when two surfaces touch each other, which prevents thecontacted surfaces from being exposed to the “applied agent” (20). Thiscauses a shadowing effect. Of course, this challenge does not apply tothe use of ethylene oxide gas (EtO) with polymeric materials because EtOis able to penetrate that material and any shadowed surfaces over time.

The shadowing effect found with the delivery of “applied agent” (20)such as, but not limited to, aerosols (65), can be overcome in variousways. It is preferred, without limitation, that one way includes placingone or more endoscopes (01) in a sterilization chamber (16) andattaching each of them to a pressure interface assembly(s) (68) and thensuspending the endoscopes (01) in the air within the sterilizationchamber (16) via the pressure interface assembly(s) (68). Thiseliminates the chance for incomplete interaction, coating, or contact ofthe “applied agent” (20) with all of the surfaces of the endoscope (01).For example, the pressure interface assembly (68) mayinterface/articulate with either end of an endoscope (01), and theendoscope (01) may hang down toward the floor of the sterilizationchamber (16) without touching anything.

Referring to FIGS. 8-9, an alternative embodiment for suspending theendoscope (01) within the chamber (16) includes, without limitation,placing the endoscope (01) in one or more cradles (45) within thesterilization chamber (16), or encircling the endoscope (01) in one ormore places with a material (47), in order to hang it within thesterilization chamber (16). In either case, the material (47) that holdsthe endoscope (01) should be, without limitation, as thin and narrow aspossible, as well as porous, permeable, or semi-permeable. This material(47) can, without limitation, include various layers of variousmaterials suitable for this purpose and it can also be absorbent. Someof this material (47) is then interfaced, connected, or otherwiseattached to a hook(s) or other means (46), which are additionallyattached using a suitable attachment member (48) to the interior of thesterilization chamber (16), in order to hold the material (47). Thisresults in the suspension of the endoscope (01) in free space above thefloor of the closed space or sterilization chamber (16) in which it isplaced. The intent is to maximize the external surface area of theendoscope (01) that is exposed to “applied agent” (20) as well asallowing the “applied agent” (20) to quickly achieve its desired effecton the areas and surfaces that interface between the endoscope (01) andthe material that is holding it. Previous laboratory work with anultrasonic aerosol generator has shown that materials like glassine haveshown sufficient permeability with the administration of an aerosol (65)having the preferred disinfectant or “applied agent” (20) containedtherein. A high level of disinfection on the opposing side of thisexample barrier material (47) was achieved.

The shadowing can also be overcome by the incorporation and use ofmovable fork(s) or beam(s) (49),(50) within the closed space orsterilization chamber (16) of the present invention, as shown in FIGS.10-11. The endoscope (01) is first placed or positioned on one or morebeam(s) or fork(s) (herein “start beams”) (49). One or more beam(s) orfork(s) (herein“opposing beams”) (50) are also provided and they areintended to loosely interlock or intermesh with and/or oppose the startbeams (49) without touching the start beams (49). The beams or forks(49),(50) can vary in size and shape as desired. The start beams (49) oropposing beams (50) can be designed or constructed so that the endoscope(01) will not roll or move off of the beams. In order to maintain theposition of the endoscope (01) on the various beams (49),(50), they canhave one or more, without limitation, indentations, ridges, bumps, orprotrusions of various sizes, shapes, and heights. They may also,without limitation, slope or curve upward at various angles at locationsincluding, but not limited to the ends of the beams (49),(50). Duringthe application of the “applied agent” (20), the start beams (49) oropposing beams (50) move, by way of any mechanical means that are knownin the art, resulting in the transfer of the endoscope(s) (01) so thatit is moved from either the start beams (49) to the opposing beams (50)or from the opposing beams (50) to the start beams (49). This allows allof the endoscope (01) surfaces to be covered with the “applied agent”(20) as a result of exposing those portions of the surface of theendoscope (01) covered by the beams (49) when the endoscope (01) ismoved onto the beams (50), or vice versa. These beams (49),(50) can thenreverse their movement during the drying cycle to allow all of theendoscope (01) surfaces to dry if it is necessary. The movement of thebeams (49),(50) can vary, without limitation, in speed and range ofmotion, and are controlled in a manner well known in the art. Anydigital or analog controller known to those skilled in the art can,without limitation, control the operation of the movable fork(s) orbeam(s) (49),(50), as discussed later. A digital controller such as, butnot limited to any programmable logic circuit (PLC) or other means knownto those skilled in the art can, without limitation, control theoperation of and be signaled the status of, the movable fork(s) orbeam(s) (49),(50), all in way know. The status of the movable fork(s) orbeam(s) (49),(50) can, without limitation, signal and initiate otherprocesses such as, but not limited to, the commencement of any dryingactivities. The beams (49),(50) maybe constructed from the samematerials used to construct the sterilization chamber (16) or pressureinterface assembly (68).

The closed space, closed system of space, or sterilization chamber (16)can be purged, flowed, and/or filled with air or other gas from theoutside environment (fresh filtered air) either before and/or after the“applied agent” (20) or other liquids are administered or applied in thesterilization chamber (16). The fresh air/gas is moved into the closedspace, closed system of space, or sterilization chamber (16) via anyair/gas pump, vacuum pump, blower, fan, or other means to move air, orsource of pressurized air or gas (17),(51) and can move the fresh air atvarious volumes, rates, or speed. In either case, this can contribute tothe removal of moisture, liquids, and/or “applied agent” (20) from thesurfaces of the endoscope (01), and other surfaces and areas within theclosed space or sterilization chamber (16). The time needed toeffectively remove the moisture, liquids, and/or “applied agent” (20)that had coated, interfaced, interacted, enveloped, or had contact withthe surfaces, or filled areas, within the closed area or sterilizationchamber (16), is dependent on variables such as, but not limited to, theapplication time, temperature, relative humidity, flow rate, volume, andvelocity, of the fresh air. It can also include the temperature of thetargeted surfaces or endoscope (01) and/or areas. The variables can varyin order to remove the moisture, liquids, and/or “applied agent” (20)from these surfaces and areas in a manner that is as quick and effectiveas possible. The air/gas from the outside environment (fresh filteredair) can also be used to remove moisture, liquids, and/or “appliedagent” (20) present in the interior space or ducts (08) of the endoscope(01) within the sterilization chamber (16). This can, withoutlimitation, be accomplished by operating the same air/gas pump, vacuumpump, blower, fan, or other means (44),(17) which is used to create apositive or negative air/gas pressure within the pressure interfaceassembly (68) that is attached to the object or endoscope (01), in orderto flow fresh air/gas through places such as, but not limited to, theinterior space or ducts (08) of the object or endoscope (01). This isshown in greater detail in FIGS. 4-5. The time needed to effectivelyremove the moisture, liquids, and/or “applied agent” (02) from thesurfaces in this application will vary and is affected by variablesincluding but not limited to the number, shape, diameter, and length ofthe interior spaces or ducts (08) of the endoscope (01), as well as theapplication time, temperature, relative humidity, flow rate and volume,and velocity, of the applied fresh air/gas. The variables such as, butnot limited to, the fresh air/gas's temperature, flow rate, volume,velocity, and relative humidity, can vary in order to remove themoisture, liquids, and/or “applied agent” (20) in a manner that is asquick and effective as possible. The fresh air/gas that is used in thisparticular application can be sourced from either the fresh air/gas fromthe outside environment that is flowed or moved into the sterilizationchamber (16), or it can be sourced directly from the outsideenvironment. The air/gas from the outside environment can be treated toreduce its relative humidity and can be heated to various temperaturesbefore it enters the closed space, sterilization chamber (16), orendoscope (01). The means to heat the air/gas (52) (29) is notspecifically set forth, but known to those skilled in the art. Heatingthe air/gas can contribute to the accelerated removal of any moisture,liquids, and/or “applied agent” (20) from the surfaces and areas withinthe closed space, closed system of space, or sterilization chamber (16),in addition to the external and internal surfaces or ducts (08) of theobject(s) or endoscope(s) within the closed space or sterilizationchamber (16). The air/gas from the outside environment can be filteredbefore it enters into the closed space, sterilization chamber, orendoscope (01). The fresh air/gas can be filtered with one or morefilters (53) such as but not limited to a 99.9% HEPA filter or otherhigh efficiency filter, or with other filters or means for filteringair/gas that is not specifically set forth, but known to those skilledin the art. The filter (53) can limit or prevent the contamination ofthe endoscope (01) within the closed space or sterilization chamber(16). A means for exhausting (39) the air/gas within the closed systemof space or sterilization chamber can also be incorporated into thepresent invention. This exhaust system and/or outlet or port, can alsoinclude the use of one or more filters (54) or combination of filters(54) such as, but not limited to, a gas filtering filter, 99.9% HEPAfilter or other high efficiency filter, or other filters or means forfiltering (54) that is not specifically set forth, but known to thoseskilled in the art. This means for exhaust (39) can help to establish aflow of fresh air/gas through the closed system of space orsterilization chamber (16) and allows the incoming fresh air/gas tofully replace the air/gas inside of these areas which can prevent thebuildup of positive pressure within the closed system of space orsterilization chamber (16). The exhausted flow of air/gas also helps toremove the “applied agent” (20) from the closed system of space orsterilization chamber (16). The filter(s) (54) can prevent thecontamination of objects or endoscopes (01) within the closed system ofspace or sterilization chamber (16) by filtering any potential backflowof air and/or gases, as well as filter and remove any “applied agent”(20), or any contaminants, in the air/gas before they are exhausted outof the present invention and into the external environment. In manysituations, air and gas filtering standards are dictated or impacted byregulatory entities, or by standards set within the industry in whichthe present invention operates. This may also affect the type or meansof air and/or gas filters (53),(54) that are used in the presentinvention. The fresh air/gas can also be moved into and through theclosed system of space or sterilization chamber (16) by locating a meansto move the air/gas such as but not limited to an air/gas pump, vacuumpump, blower, or fan, (17),(51) as earlier described, at or near theexhaust air/gas outlet (39). The means (17),(51) to move the air/gas canbe located before or after any of the filter(s) (53),(54) that filtersthe inbound or exhausted air/gas.

Referring to FIG. 13, the fresh air/gas is moved with a blower, fan, orother source of pressurized air/gas (17),(51), and is then passedthrough a means to filter the inbound air/gas (53) so that the inboundair/gas cannot contaminate the endoscope (01) inside of the closed spaceor sterilization chamber (16). The inbound fresh air/gas may also beheated by any means that can heat air/gas (52). The means to move,filter, and heat the air/gas can be in any order. The air/gas is thencirculated, moved, or flowed into the closed space or sterilizationchamber (16). An exhaust air/gas outlet (39) is used to ventilate theair/gas and the “applied agent” (20), out of the closed system of spaceor sterilization chamber (16). The vented air/gas can also pass throughone or more filters (54) before it is ventilated into the externalenvironment. One or more means (35) are also present to effectivelyclose off, seal, or separate, the closed system of space orsterilization chamber(s) (16) from the inbound fresh air/gas inlet (38),the outbound or exhaust air/gas outlet (39), and/or any of the tubes,ducting, channels, tunnels, etc., that connect the fresh air/gas inletor exhaust air/gas outlet to the closed system of space or sterilizationchamber (16). The said means (35) can be a door, flap, valve, lid,panel, or other physical means to contain the “applied agent” (20) orany air/gas that is utilized or applied or administered, as well as theagents or substances that are used to wash the endoscopes (01) asdiscussed earlier.

According to an embodiment, one or more means to remove humidity (74)from within the sterilization chamber(s) (16) or other area(s) where the“applied agent” (20) in aerosol form (65) is applied may also, withoutlimitation, be located within the sterilization chamber(s) (16) or othertargeted area(s), or otherwise be operatively coupled or attached toand/or about the sterilization chamber (16), or anywhere along the pathof any circulated or recirculated air/gas (31) and aerosol (65), orother connected spaces. It is preferred, without limitation, that thedehumidification activity occurs any time after the application of the“applied agent” (20) in aerosol form (65), which is unique in comparisonto the prior art. The prior art teaches that dehumidification is anecessary activity for achieving efficacious results before theapplication of certain applied agent such as, but not limited to,vaporized hydrogen peroxide, and is therefore not claimed in the presentinvention. However, dehumidification activities can, without limitation,take place any time during the processing of the endoscope in thepresent invention. The use of one or more dehumidification apparatus(s)(74) in the present invention is beneficial in situations that include,but are not limited to, where the air/gas and/or the “applied agent”(20) in aerosol form (65) within the sterilization chamber(s) (16) ortargeted area(s) cannot be evacuated for reasons known to those skilledin the art. The dehumidification apparatus (74) is constructed andoperated in a manner known to those skilled in the art, and includes,but is not limited to a dehumidification means where air/gas from thetargeted environment is moved over any chilled media, to remove thehumidity. The dehumidification apparatus(s) (74) may reduce or evensustain the humidity level to any desired level or percentage ofhumidity, and in a manner that is known to those skilled in the art.However, it is preferred, without limitation, that if thedehumidification apparatus (74) is operated, it reduces the humidity toa level that is at least efficacious or meets standards known to thoseskilled in the art. It is more preferred that the humidity is reduced toa level that is equal to or less than 50% relative humidity. It is evenmore preferred that the humidity is reduced to a level that is equal toor less than 20% relative humidity. After the sterilization chamber(s)(16) or other targeted area(s) are dehumidified the air/gas within thesespaces may be processed in a manner known to those skilled in the art toremove any substances such as, but not limited to, any remaining odors,chemicals, smells, vapors, aerosols, or gases. This can be accomplishedin ways that include, but are not limited to, passing the air/gas in thesterilization chamber(s) (16) or other targeted area(s) through anyfilter (75) that contains carbon, charcoal, or any other applicablefiltering means known to those skilled in the art. The processed air/gascan be, without limitation, returned back to the sterilizationchamber(s) (16) or any space connected to the sterilization chamber(s)(16).

The effective operation of the present invention can be accomplishedusing any electrical and/or electronic means to control the mechanismsthat the present invention depends on for its proper function. Theelectrical and electronic means can be programmed or electricallydesigned to execute, manage, monitor, or control, the present inventionand are not specifically set forth, but known to those skilled in theart. This means can monitor and control the function, as well as thetiming of use, of any electrically dependent components such as, but notlimited to, any valves, any means used for the production of the“applied agent” (20) used in the present invention as well as anyrelated mechanisms or systems, any means used to flow or move theair/gas and/or “applied agent” (20) within or out of the presentinvention, any means to heat the aerosol, air/gas, or floor of thesterilization chamber, any means used to flow or move the air/gas and/or“applied agent” (20) through the internal spaces or ducts (08) of theobject or endoscope (01), any packaging equipment or related systems, aswell as any other microcomputers that are used, such as but not limitedto, microcomputers or printers utilized to record and report theoperating parameters of each cycle of use.

According to an embodiment, the present invention also improves thecurrent art by decreasing the processing time for the simultaneous ornon-simultaneous cleaning and disinfection/sterilization of both theinterior and exterior surfaces of an object or plurality of objects suchas, but not limited to, an endoscope (01). It is more preferred, withoutlimitation, that the activities such as, but not limited to, thewashing, cleaning, disinfection/sterilization, rinsing, and drying, ofboth the interior and exterior surfaces of an endoscope (01) orplurality of endoscopes (01) take place within the same sterilizationchamber (16). The pressure interface assembly (68) of the presentinvention may or may not be used, without limitation, in thisembodiment. However, it is preferred, without limitation, that thepressure interface assembly (68) is not used in this particularembodiment, and that the endoscope (01) is connected to a pipe, hose,tube, or other delivery means that can supply any surfactant, rinseliquid, or applied agent to the endoscope (01), or otherwise a supplytube (11).

Initially, processing steps utilized in the current art are followed inthis embodiment and involve the use of a washer (72) or other device ormeans, known to those skilled in the art, for activities including, butnot limited to, cleaning, washing, or disinfecting/sterilizingendoscopes (01) (herein called “washer”) (72). (Where is this devicelocated exactly in FIG. 12?) The washer (72) may, without limitation, beintegrated into the design or construction of the enclosed area,chamber, or sterilization chamber (16) of the present invention. Thesesteps are known to those skilled in the art and include, but are notlimited to, wiping or cleaning the endoscope (01) to remove, or attemptremoval of, any unwanted liquid, debris, contaminants, or othersubstances, and then placing the endoscope (01) into a washer (72) andinterfacing it with a supply tube (11). The endoscope (01) is placed ona rack, or other means known to those skilled in the art, to hold orposition the endoscope (01) within the sterilization chamber (16) and/orwasher (72). The supply tube (11) enables various liquids including butnot limited to, surfactant, and high purity rinse water, to be movedthrough the various ducts (08) of the endoscope (01) at various stagesof the cleaning process. The washer (72) then subjects, sprays, covers,floods, or a combination thereof, the endoscope (01) with liquids orcompounds such as, but not limited to, surfactants or other cleaningliquids, both inside and outside of the object or endoscope (01) in amanner known to those skilled in the art. After this cycle is completed,the inside as well as outside surfaces of the object or endoscope (01)may be exposed to a liquid rinse, which may consist of one or moreliquids that includes high purity water. It is preferred, withoutlimitation, that the endoscope (01) is rinsed with high purity water.Any surfactant solution and rinse liquid can be used and it may be anytemperature when it is used. It is preferred, without limitation, thatthe surfactant used in the present invention is any surfactant thatmeets standards acceptable to the industry in which it is used, as wellas any regulatory requirements. It is preferred, without limitation,that the rinse liquid used in the present invention is any high purityrinse water that meets standards acceptable to the industry in which itis used, as well as any regulatory requirements. The cycle time for theexposure of the endoscope (01) to any surfactant and rinse liquid canvary but is at least efficacious. In order to decrease the processingtime, improvements are made at this point to the current art.

According to an embodiment, any or all attributes, functions, features,or designs of the endoscope washer (72) utilized in the current art maybe integrated into the sterilization chamber (16) that is previouslydescribed in the present invention.

According to another embodiment after the endoscope (01) is treated withany surfactant and/or rinse water, its internal and external surfacesmay be dried. Any drying technique previously described in the presentinvention or known to those skilled in the art can be utilized in thisembodiment. It is preferred that any air/gas that may be heated and/orfiltered is flowed or otherwise moved into the sterilization chamber(16) and/or washer (72) in which the endoscope (01) is positioned inorder to dry it. The creation of a vacuum within the sterilizationchamber (16), of various negative atmospheric pressures, but at least anefficacious level of vacuum, may also be used for drying purposes. Thelevel or amount of dryness can vary. The drying of the internal andexternal surfaces of the endoscope (01) can be done simultaneously or atdifferent times, or it can be treated as mutually exclusive activitiesthat can or cannot be undertaken. It is preferred, without limitation,that all of the internal and external surfaces of the endoscope (01) aredried and that this activity is done simultaneously.

The internal surfaces of the endoscope (01) can be dried, withoutlimitation, by flowing air/gas through the supply tube (11) and thenthrough the endoscope (01). The air/gas can be heated and/or filtered.The air/gas, or other means used for surface drying, may be applied forany length of time to any surfaces of the endoscope (01).

According to an embodiment, the supply tube (11) is, without limitation,designed, manufactured, and incorporated, into the design of thesterilization chamber (16) and/or washer (72), and endoscope (01) in amanner known to those skilled in the art. The supply tube (11) may alsobe effectively connected to any supply of, including, but not limitedto, air/gas, liquid surfactant, liquid for rinsing, and source ofapplied agents, in a manner known to those skilled in the art. Thevarious controlled access points or valves (35) that control theexposure of the endoscope (01) to various substances such as, but notlimited to, air/gas, liquid surfactant, liquid for rinsing, andanti-pathogen/toxin/fungal/sporicidal agent(s) or substance(s), to thesupply tube (11) or endoscope (01) can be, without limitation, designedand controlled in a manner known to those skilled in the art.

According to a preferred embodiment, after the endoscope (01) undergoesvarious activities such as, but not limited to, cleaning withsurfactant, rinsing with water and optionally alcohol in separate steps,and drying (if desired), the inside and outside surfaces of theendoscope (01) are treated with an anti-pathogen/toxin/fungal/sporicidalagent(s) or substance(s) that is, in the form of any aerosol. Theapplied agents are created, generated, and/or administered in or intothe sterilization chamber (16) and/or washer (72) in which the endoscope(01) are placed. It is preferred that the treated surfaces are driedbefore the anti-pathogen/toxin/fungal/sporicidal agent(s) orsubstance(s) is applied, such as by passing a drying gas over thesurfaces of the endoscope (01). This may enhance the efficacy or cycletime of the process. It is preferred, without limitation, that theapplied agent is an aqueous aerosol (65), consisting of, but not limitedto, any acidic oxidizer, generated by one or more of any transducer (22)or ultrasonic nebulizer(s) (22) of any design or construction. Theaerosol (65) may be of any concentration, number, size, or density,however it is preferred, without limitation, that the aerosol (65)consists generally of droplets whose size is five micron or less. Theaerosol (65) can be generated from any liquid that is at anytemperature. The aerosol (65) is delivered to the internal surfaces,areas, or ducts (08) of the endoscope (01) via a supply tube (11). Thisparticular embodiment may improve the current art by significantlydecreasing the endoscope (01) processing time.

According to an embodiment, the applied agent that is used to treat theendoscope (01) may also be in the form of any gas, plasma, or vapor. Theprior art includes the use of an applied liquid agent through thevarious internal spaces such as, but not limited to the ducts (08) of anendoscope (01), as well as over the various external surfaces of theendoscope (01), and is therefore not claimed in the present invention.

After this cycle is completed, the ducts (08) or internal, as well asexternal surfaces of the endoscope (01) may be exposed or subjected to aliquid rinse, which includes one or more liquids, substances, orcompounds, that includes, but is not limited to high purity water oralcohol, all in a manner known to those skilled in the art. Theendoscope (01) can then be removed from the sterilization chamber (16)and/or washer (72) and hung to dry.

According to another embodiment as an alternative to hanging theendoscope (01) to dry, the inside and outside surfaces of the endoscope(01) are dried with various means such as, but not limited to, adehumidification apparatus(s) (74), formation of a negative atmosphericpressure or vacuum in the sterilization chamber (16), or air/gas orheated air/gas, before it is removed from the sterilization chamber (16)and/or washer (72). It is preferred that the air/gas is heated. Theair/gas can be heated in a manner known to those skilled in the art. Thesupply tube (11) may be used to supply air or heated air to the insidesurfaces or ducts (08) of the endoscope (01).

According to a preferred embodiment, after the endoscope (01) undergoesvarious activities such as cleaning with surfactant, rinsing, drying (ifdesired), and the inside and outside surfaces of the endoscope (01) arethen treated with an applied agent, the final rinsing activity(s) arenot utilized and the endoscope is instead subjected to the final dryingactivity. This offers the benefit of significantly reducing processingtime. It is preferred that this is conducted with an “applied agent”(20) in the form of an aqueous aerosol (65), including, but not limitedto, any acidic oxidizer, generated by one or more of any transducer (22)or ultrasonic nebulizer(s) (22) of any design or construction. However,this embodiment can also pertain to any gas, plasma, vapor, and/oraerosol that is utilized.

Various other embodiments of the present invention are contemplated asbeing within the scope of the following claims.

We claim:
 1. A method of treating at least one object with an agent,comprising the steps of: providing an enclosed chamber adapted toreceive at least one object therein; supplying an agent in the form ofan aerosol; providing at least one flow interface disposed within theenclosed chamber, each one of said at least one flow interface includesa coupling member and an interface material, one end of said couplingmember is connected to a supply of the agent, the other end of saidcoupling member is sized to receive one end of said interface material,said interface material includes an inner perimeter which is sized toreceive an outer perimeter of one of the at least one object, saidinterface material is at least one of permeable and absorbent, such thatthe agent flows through an entire cross section of said interfacematerial, the agent treats the surface area of one of the at least oneobject covered by said interface material; and flowing the aerosolthrough said at least one flow interface and interior spaces of one ofthe at least one object.
 2. The method of treating at least one objectwith an agent of claim 1, further comprising the step of: securing oneof said at least one flow interface and said interface material to theat least one object with a securement device.
 3. The method of treatingat least one object with an agent of claim 2, further comprising thestep of: inflating said securement device.
 4. The method of treating atleast one object with an agent of claim 1, further comprising the stepof: applying agent to an exterior surface of one of the at least oneobject.
 5. The method of treating at least one object with an agent ofclaim 1, further comprising the step of: providing a positive/negativeair pressure generating device connected to said at least one flowinterface to create the positive or negative pressure within said atleast one flow interface.
 6. The method of treating at least one objectwith an agent of claim 5, further comprising the step of: connecting oneof an input and an output of said positive/negative air pressuregenerating device to said at least one flow interface, connecting one ofsaid output and said input to said enclosed chamber to form a closedloop for the flow of the agent through one of the at least one object.7. The method of treating at least one object with an agent of claim 1,further comprising the step of: providing the aerosol with dropletshaving a size of 5 microns or less.
 8. A method of treating at least oneobject with an agent, comprising the steps of: providing an enclosedchamber adapted to receive at least one object therein; supplying anagent in the form of an aerosol, the agent includes peroxyacetic acid,the aerosol being generated by a ultrasonic transducer; providing atleast one flow interface disposed within the enclosed chamber, each oneof said at least one flow interface includes a coupling member and aninterface material, one end of said coupling member is connected to asupply of the agent, the other end of said coupling member is sized toreceive one end of said interface material, said interface materialincludes an inner perimeter which is sized to receive an outer perimeterof one of the at least one object, said interface material is at leastone of permeable and absorbent, such that the agent flows through anentire cross section of said interface material, the agent treats thesurface area of one of the at least one object covered by said interfacematerial; and flowing the aerosol through said at least one flowinterface and interior spaces of one of the at least one object.
 9. Themethod of treating at least one object with an agent of claim 8, furthercomprising the step of: applying agent to an exterior surface of one ofthe at least one object.
 10. The method of treating at least one objectwith an agent of claim 8, further comprising the step of: providing apositive/negative air pressure generating device connected to said atleast one flow interface to create the positive or negative pressurewithin said at least one flow interface.
 11. The method of treating atleast one object with an agent of claim 10, further comprising the stepof: connecting one of an input and an output of said positive/negativeair pressure generating device to said at least one flow interface,connecting one of said output and said input to said enclosed chamber toform a closed loop for the flow of the agent through one of the at leastone object.
 12. The method of treating at least one object with an agentof claim 8, further comprising the step of: providing an object supportdevice for supporting one of the at least one object within the enclosedchamber to maximize the exposed surface of one of the at least oneobject.
 13. The method of treating at least one object with an agent ofclaim 8, further comprising the step of: providing the aerosol withdroplets having a size of 5 microns or less.
 14. A method of treating atleast one object with an agent, comprising the steps of: providing anenclosed chamber; supplying an agent in the form of an aerosol;providing at least one flow interface disposed within the enclosedchamber, each one of said at least one flow interface includes acoupling member and an interface material, one end of said couplingmember is connected to a supply of the agent, the other end of saidcoupling member is sized to receive one end of said interface material,said interface material includes an inner perimeter which is sized toreceive an outer perimeter of one of the at least one object, saidinterface material is at least one of permeable and absorbent, such thatthe agent flows through an entire cross section of said interfacematerial, the agent treats the surface area of one of the at least oneobject covered by said interface material; inserting the at least oneobject into a package, connecting said at least one flow interface tosaid package, said package is made at least in part from a flexiblematerial, inserting said package into said enclosed chamber; and flowingthe aerosol through said at least one flow interface and interior spacesof one of the at least one object, after said package is inserted intosaid enclosed chamber.
 15. The method of treating at least one objectwith an agent of claim 14, further comprising the step of: applyingagent to an exterior surface of said package.
 16. The method of treatingat least one object with an agent of claim 14, further comprising thestep of: providing a positive/negative air pressure generating deviceconnected to said at least one flow interface to create the positive ornegative pressure within said at least one flow interface.
 17. Themethod of treating at least one object with an agent of claim 16,further comprising the step of: connecting one of an input and an outputof said positive/negative air pressure generating device to said atleast one flow interface, connecting one of said output and said inputto said enclosed chamber to form a closed loop for the flow of the agentthrough one of the at least one object.
 18. The method of treating atleast one object with an agent of claim 14, further comprising the stepof: providing an object support device for supporting one of the atleast one object within the enclosed chamber to maximize the exposedsurface of one of the at least one object.
 19. The method of treating atleast one object with an agent of claim 14, further comprising the stepof: connecting a gas inlet to said enclosed chamber to draw in a gas tobe combined with the agent to form the flow of the agent; and connectingan exhaust outlet to said enclosed chamber to expel at least a portionof the flow of the agent from said enclosed chamber.
 20. The method oftreating at least one object with an agent of claim 19, furthercomprising the step of: connecting the gas inlet and the exhaust outletto a flow recirculation passage connected between the enclosed chamberand a supply of the agent.
 21. The method of treating at least oneobject with an agent of claim 14, further comprising the step of:providing the aerosol with droplets having a size of 5 microns or less.